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This page lists all regulatory documents in this wiki. Use the sections below to browse by status or scope.
This page lists all regulatory documents in this wiki. Use [[GxPlex_Search|GxPlex Search]] for filter-based browsing, or [[Special:Ask|Special:Ask]] for custom queries.


== Current documents ==
== All documents ==


{{#ask: [[Status::Current]]
{{#ask: [[Document:+]]
| ?Document name = Name
| ?DocName = Document name
| ?Scope = Scope
| ?DocScopes = Scope
| ?Area of validity = Region
| ?DocValidityArea = Region
| ?Document type = Type
| ?DocStatus = Status
| ?DocType = Type
| format=table
| headers=show
| limit=500
| sort=DocName
| order=asc
}}
 
== By status ==
 
=== Current ===
 
{{#ask: [[Document:+]] [[DocStatus::Current]]
| ?DocName = Document name
| ?DocScopes = Scope
| ?DocValidityArea = Region
| ?DocType = Type
| format=table
| headers=show
| limit=200
| sort=DocName
| order=asc
}}
 
=== Draft ===
 
{{#ask: [[Document:+]] [[DocStatus::Draft]]
| ?DocName = Document name
| ?DocScopes = Scope
| ?DocValidityArea = Region
| format=table
| format=table
| headers=show
| headers=show
| limit=100
| limit=100
| sort=Scope
| sort=DocName
}}
}}


== Grouped by scope ==
=== Superseded ===


=== Medical Devices (MD) ===
{{#ask: [[Document:+]] [[DocStatus::Superseded]]
| ?DocName = Document name
| ?DocScopes = Scope
| ?DocValidityArea = Region
| format=table
| headers=show
| limit=100
| sort=DocName
}}
 
== By scope ==
 
=== Human Medicines (HM) ===


{{#ask: [[Scope::~*MD*]]
{{#ask: [[Document:+]] [[DocScopes::~*HM*]]
| ?Document name = Name
| ?DocName = Document name
| ?Status = Status
| ?DocStatus = Status
| ?Area of validity = Region
| ?DocValidityArea = Region
| format=table
| format=table
| headers=show
| headers=show
| limit=50
| limit=100
| sort=DocName
}}
}}


=== In Vitro Diagnostics (IVD) ===
=== Medical Devices (MD) ===


{{#ask: [[Scope::~*IVD*]]
{{#ask: [[Document:+]] [[DocScopes::~*MD*]]
| ?Document name = Name
| ?DocName = Document name
| ?Status = Status
| ?DocStatus = Status
| ?Area of validity = Region
| ?DocValidityArea = Region
| format=table
| format=table
| headers=show
| headers=show
| limit=50
| limit=100
| sort=DocName
}}
}}


=== GMP / PV / NIS ===
=== In Vitro Diagnostics (IVD) ===


{{#ask: [[Scope::~*GMP*]] OR [[Scope::~*PV*]] OR [[Scope::~*NIS*]]
{{#ask: [[Document:+]] [[DocScopes::~*IVD*]]
| ?Document name = Name
| ?DocName = Document name
| ?Scope = Scope
| ?DocStatus = Status
| ?Status = Status
| ?DocValidityArea = Region
| format=table
| format=table
| headers=show
| headers=show
| limit=50
| limit=100
| sort=DocName
}}
}}


== Draft and not yet promulgated ==
=== GMP / PV / NIS ===


{{#ask: [[Status::Draft]] OR [[Status::Final not promulgated]]
{{#ask: [[Document:+]] [[DocScopes::~*GMP*]] OR [[Document:+]] [[DocScopes::~*PV*]] OR [[Document:+]] [[DocScopes::~*NIS*]]
| ?Document name = Name
| ?DocName = Document name
| ?Scope = Scope
| ?DocScopes = Scope
| ?Area of validity = Region
| ?DocStatus = Status
| format=table
| format=table
| headers=show
| headers=show
| limit=50
| limit=100
| sort=DocName
}}
}}


== Superseded ==
== References ==


{{#ask: [[Status::Superseded]]
{{#ask: [[Reference:+]]
| ?Document name = Name
| ?HasDocument = Document
| ?Scope = Scope
| ?RefScope = Scope
| ?RefLanguage = Language
| format=table
| format=table
| headers=show
| headers=show
| limit=50
| limit=200
| sort=HasDocument
}}
}}

Latest revision as of 20:54, 27 June 2026

This page lists all regulatory documents in this wiki. Use GxPlex Search for filter-based browsing, or Special:Ask for custom queries.

All documents

 Document nameScopeRegionStatusType
N.A. (STROBE)statement: guidelines for reporting observational studies Apr-2008(STROBE)statement: guidelines for reporting observational studiesINSN.A.N.A.International guideline
EU 2011/C 172/01 - CT-3 11-Jun-20112011/C 172/01 - CT-3GEUCurrentRegulatory requirement
USA 21 CFR Part 11 09-Apr-202521 CFR Part 11GUSACurrentLegal act
USA 21 CFR Part 312 09-Apr-202521 CFR Part 312HMUSACurrentLegal act
USA 21 CFR Part 314 09-Apr-202521 CFR Part 314HMUSACurrentLegal act
USA 21 CFR Part 320 09-Apr-202521 CFR Part 320HMUSACurrentLegal act
USA 21 CFR Part 50 09-Apr-202521 CFR Part 50GUSACurrentLegal act
USA 21 CFR Part 54 09-Apr-202521 CFR Part 54GUSACurrentLegal act
USA 21 CFR Part 56 09-Apr-202521 CFR Part 56GUSACurrentLegal act
USA 21 CFR Part 809 06-May-202421 CFR Part 809GUSACurrentLegal act
USA 21 CFR Part 812 09-Apr-202521 CFR Part 812MDUSACurrentLegal act
USA 42 CFR Part 11 09-Apr-202542 CFR Part 11GUSACurrentLegal act
USA 45 CFR Part 160 09-Apr-202545 CFR Part 160GUSACurrentLegal act
USA 45 CFR Part 46 09-Apr-202545 CFR Part 46GUSACurrentLegal act
FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025AEC-DM-DMDIV_DOC006 v04 AAP_RDM_Partie II_Modalités pratiquesMDFRACurrentOfficial recommendation
FRA AEC DOC010 V.04 01-Jun-2018AEC_DOC010 V.04HMFRACurrentOfficial recommendation
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie IIMDFRACurrentOfficial recommendation
DEU AMG - Arzneimittelgesetz 19-Jul-2023AMG - ArzneimittelgesetzHM ; NIS ; OtherDEUCurrentLegal act
AUT AMG – Arzneimittelgesetz 04-Mar-2023AMG – ArzneimittelgesetzHMAUTCurrentLegal act
DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnungMD ; HMDEUCurrentRegulatory requirement
AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021AVG – Allgemeines Verwaltungsverfahrens-gesetzGAUTCurrentLegal act
USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018Acceptance of Clinical Data to Support

Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and

Food and Drug Administration Staff		MDUSACurrentOfficial recommendation
N.A. Article from Mora et al. 2023Article from Mora et al.GN.A.N.A.Litterature article
AUT BASG - FAQ 11-Feb-2025BASG - FAQGAUTSuperseded / InvalidInformation from official body
DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023BGB - Bürgerliches GesetzbuchOtherDEUCurrentLegal act
FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL)GFRACurrentOfficial recommendation
DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und FormOtherDEUCurrentRegulatory requirement
EU CHMP Guidelines -CHMP GuidelinesHMEUN.A.Corpus of texts
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016CIOMS - International Ethical

Guidelines for Health-related Research

Involving Humans		GCIOMSCurrentInternational guideline
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016CIOMS - International Ethical Guidelines for Biomedical Research Involving Human SubjectsGCIOMSCurrentInternational guideline
CIOMS CIOMS Publications -CIOMS PublicationsGCIOMSN.A.Corpus of texts
EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022COMMISSION IMPLEMENTING DECISION (EU) 2022/729MD ; IVDEUCurrentRegulatory requirement
USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)CTCAE - Common Terminology Criteria for Adverse EventsGUSACurrentOfficial recommendation
GBR Clinical Trial toolkit 28-Jan-2025Clinical Trial toolkitGGBRCurrentInformation from official body
GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021Clinical investigations of medical devices – compiling a submission to MHRAMDGBRCurrentOfficial recommendation
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025Code de la Santé Publique

- Partie Réglementaire -

1ere partie, Livre 1er, Titre II		GFRACurrentLegal act
FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025Code de la Santé Publique

- Partie législative -

1ere partie, Livre 1er, Titre II		GFRACurrentLegal act
FRA Constitution du 4 octobre 1958 10-Mar-2024Constitution du 4 octobre 1958GFRACurrentLegal act
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018DGEPi - GEP Guter Epidemiologischer PraxisNISDEUCurrentOfficial recommendation
FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007DHOS/E1/DAF/DPACI no 2007-322GFRACurrentRegulatory requirement
GBR Data Protection Act 2018 06-Jun-2022Data Protection Act 2018GGBRCurrentLegal act
WMA Declaration of Helsinki 2024Declaration of HelsinkiGWMACurrentInternational guideline
DEU Deutsches Ärzteblatt 45849Deutsches ÄrzteblattGDEUCurrentInformation from official body
GBR Directive 2001/20/EC 04-Apr-2001Directive 2001/20/ECHMGBRCurrentLegal act
EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12Directive 2001/83/EC - Community code relating to medicinal products for human useNISEUCurrentRegulatory requirement
GBR Directive 90/385/EEC 05-Sep-2007Directive 90/385/EECMDGBRCurrentLegal act
GBR Directive 93/42/EEC 11-Oct-2007Directive 93/42/EECMDGBRCurrentLegal act
GBR Directive 98/79/EC 20-Dec-2011Directive 98/79/ECIVDGBRCurrentLegal act
EU EMA Guidelines -EMA GuidelinesHMEUN.A.Corpus of texts
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022EMA/298712/2022 - Complex clinical trials – Questions and answersHMEUCurrentInformation from official body
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator siteGEUCurrentOfficial guideline
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021EMA/698382/2021

- Guideline for the notification of serious breaches of

Regulation (EU) No 536/2014 or the clinical trial protocol		GEUCurrentOfficial guideline
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022EMA/786433/2022

Annex V – to guidance for the conduct of good clinical practice inspections – Phase I

units		GEUCurrentOfficial guideline
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023EMA/INS/GCP/112288/2023

- Guideline on computerised systems and electronic data in

clinical trials		GEUCurrentOfficial guideline
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023EMA/INS/GCP/126568/2023

- Annual Report of the Good Clinical Practice (GCP)

Inspectors' Working Group (IWG) 2022		GEUCurrentOfficial guideline
EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022EMA/INS/GCP/143492/2022

- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP:

INVESTIGATOR SITE		GEUCurrentOfficial guideline
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018EMA/INS/GCP/856758/ 2018

Guideline on the content, management and archiving of

the clinical trial master file (paper and/or electronic)		GEUCurrentOfficial guideline
EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005EMEA/CHMP/313666/2005

- GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY:

NEED FOR POST-AUTHORISATION DATA		HMEUCurrentOfficial guideline
EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)ENCePP - Guide on Methodological Standards in PharmacoepidemiologyINSEUCurrentOfficial recommendation
DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19GDEUCurrentOfficial recommendation
EU EudraLex – Volume 10 -EudraLex – Volume 10HMEUCurrentCorpus of texts
EU Eudralex - volume 4 GMP Guidelines Annex 11 Jan-2011Eudralex - volume 4

GMP Guidelines

Annex 11		GEUN.A.Corpus of texts
EU Eudralex - volume 4 GMP Guidelines Chapter 4 Jan-2011Eudralex - volume 4

GMP Guidelines

Chapter 4		GEUN.A.Corpus of texts
EUR European Bioethics Convention 1997European Bioethics ConventionGEURCurrentInternational treaty
EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025GEUCurrentInformation from official body
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review ProcedureGUSACurrentOfficial recommendation
AUT FAQ - COVID-19 Studien 15-Mar-2021FAQ - COVID-19 StudienGAUTSuperseded / InvalidInformation from official body
USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023FD&C Act - Federal Food, Drug, and Cosmetic ActMD ; OtherUSACurrentLegal act
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for IndustryGUSACurrentOfficial recommendation
USA FDA - HUMAN DRUG CGMP NOTES Volume 8, Number 3FDA - HUMAN DRUG CGMP NOTESGUSASuperseded / InvalidOther
USA FDA Guidance for Clinical Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs — Improving Human Subject Protection Jan-2009FDA Guidance for Clinical

Investigators, Sponsors, and IRBs Adverse Event Reporting to IRBs —

Improving Human Subject Protection		GUSASuperseded / InvalidOfficial recommendation
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study SubjectsGUSACurrentOfficial recommendation
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015FDA Guidance for Industry -

Computerized Systems Used in

Clinical Trials		GUSACurrentOfficial recommendation
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007FDA Guidance for Industry -

Computerized Systems Used in

Clinical Investigations		GUSACurrentOfficial recommendation
USA FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency Mar-2020FDA Guidance for Industry - Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health EmergencyGUSASuperseded / InvalidOfficial recommendation
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013FDA Guidance for Industry - Electronic Source Data in Clinical InvestigationsGUSACurrentOfficial recommendation
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013FDA Guidance for Industry -

Oversight of Clinical Investigations —

A Risk-Based Approach to Monitoring		GUSACurrentOfficial recommendation
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998FDA INFORMATION SHEET -

Recruiting Study Subjects,

Guidance for Institutional Review Boards and Clinical Investigators		HMUSACurrentOfficial recommendation
USA FDA Information - Observations and citations 20-Mar-2024FDA Information - Observations and citationsGUSACurrentInformation from official body
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOLHMGBRCurrentOfficial guideline
EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMICGEUCurrentOfficial recommendation
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)GVP: Module VIII EMA/813938/2011NISEUCurrentOfficial guideline
EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)GVP: Module XVI EMA/204715/2012GEUCurrentOfficial guideline
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studienNISDEUCurrentOfficial recommendation
GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447Guidance Access to Electronic Health Records by Sponsor representatives in clinical trialsGGBRCurrentOfficial recommendation
GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021Guidance Managing clinical trials during Coronavirus (COVID-19)GGBRCurrentOfficial recommendation
GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015Guidance - Good clinical practice for clinical trialsHMGBRCurrentOfficial recommendation
FRA Guide de légistique 07-Feb-2024Guide de légistiqueGFRACurrentInformation from official body
GBR HRA - Ending your project 28-Jan-2025HRA - Ending your projectGGBRCurrentOfficial recommendation
ICH ICH E11 Guideline R1 (2017)ICH E11 GuidelineGICHCurrentInternational guideline
ICH ICH E19 Guideline 2022ICH E19 GuidelineGICHCurrentInternational guideline
ICH ICH E21 Concept paper 2023ICH E21 Concept paperGICHN.A.International guideline
ICH ICH E2A Guideline 1994ICH E2A GuidelineGICHCurrentInternational guideline
ICH ICH E2F Guideline 2010ICH E2F GuidelineGICHCurrentInternational guideline
ICH ICH E3 Guideline 1995ICH E3 GuidelineGICHCurrentInternational guideline
ICH ICH E6 Guideline R3 (2025)ICH E6 GuidelineHMICHCurrentInternational guideline
ICH ICH E6 Guideline - Annex 2 R3 Annex 2ICH E6 Guideline - Annex 2HMICHDraftInternational guideline
ICH ICH E7 Guideline 1993ICH E7 GuidelineGICHCurrentInternational guideline
ICH ICH E8 Guideline R1 (2021)ICH E8 GuidelineHMICHCurrentInternational guideline
ICH ICH E9 Guideline 1998ICH E9 GuidelineHMICHCurrentInternational guideline
ICH ICH E9 Guideline - Addendum R1 20-Nov-2019ICH E9 Guideline - Addendum R1HMICHCurrentInternational guideline
ICH ICH Guidelines -ICH GuidelinesHMICHN.A.Corpus of texts
IMDRF IMDRF – Guidelines -IMDRF – GuidelinesMDIMDRFN.A.Corpus of texts
EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012INS/GCP/46309/2012

- Classification and analysis of the GCP inspection findings

of GCP inspections conducted at the request of the CHMP		GEUCurrentInformation from official body
GBR IRAS - Integrated Research Application System 28-Jan-2025IRAS - Integrated Research Application SystemGGBRCurrentInformation from official body
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020ISO 14155 - Clinical investigation of medical devices for human subjectsMDISOCurrentInternational guideline
INT ISPE - GPP Revision 3 (2015)ISPE - GPPINSINTCurrentInternational guideline
FRA Infographie - La hiérarchie des normes 22-Mar-2024Infographie - La hiérarchie des normesGFRACurrentInformation from official body
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and SponsorsGUSACurrentOfficial recommendation
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022KPBV - Klinische Prüfung-Bewertungsverfahren-VerordnungHMDEUCurrentRegulatory requirement
AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024LekV – Leit-Ethikkommissions-VerordnungGAUTCurrentRegulatory requirement
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021MBO - Berufsordnung der Ärzt:innenGDEUCurrentRegulatory requirement
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020MDCG 2020-10/1

- Safety reporting in clinical investigations

of medical devices		MDEU ; GBRCurrentOfficial recommendation
EU MDCG Guidelines -MDCG GuidelinesMDEUN.A.Corpus of texts
GBR MEDDEV 2.7/3 revision 3 May-2015MEDDEV 2.7/3 revision 3MDGBRCurrentOfficial guideline
GBR MHRA GCP Inspection Dossier template V7.0MHRA GCP Inspection Dossier templateGGBRCurrentInformation from official body
DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021MPAMIV - Medizinprodukte-Anwendermelde- und InformationsverordnungMDDEUCurrentRegulatory requirement
DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021MPBetreibV - Medizinprodukte-BetreiberverordnungMDDEUCurrentRegulatory requirement
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MPDG - Medizinprodukterecht-DurchführungsgesetzMD ; IVDDEUCurrentLegal act
AUT MPG – Medizinproduktegesetz 26-May-2022MPG – MedizinproduktegesetzMDAUTCurrentLegal act
GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021Making changes to a research study to manage the impact of COVID-19GGBRCurrentOfficial recommendation
GBR Medicines and Medical Devices Act 2021 21-Feb-2021Medicines and Medical Devices Act 2021GGBRCurrentLegal act
N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel TrainingHMN.A.CurrentOther
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024NCI GUIDELINES FOR INVESTIGATORS:

ADVERSE EVENT REPORTING REQUIREMENTS

FOR DCTD (CTEP AND CIP) INDs AND IDEs		GUSACurrentOther
GBR NHS: Records Management Code of Practice 07-Aug-2023NHS: Records Management Code of PracticeGGBRCurrentRegulatory requirement
USA NIH - SCORE Manual N.A.NIH - SCORE ManualGUSACurrentCorpus of texts
USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025NIH - SCORE Manual: Appendix Source Documents RequirementsGUSACurrentOfficial recommendation
USA NIH - Glossary 27-May-2025NIH - GlossaryNISUSACurrentInformation from official body
GBR NIHR - National Institute for Health and Care Research 28-Jan-2025NIHR - National Institute for Health and Care ResearchGGBRCurrentInformation from official body
GBR National Health Service Act 2006 02-Dec-2019National Health Service Act 2006GGBRCurrentLegal act
INT Nuremberg Code 1947Nuremberg CodeGINTN.A.Jurisprudence
AUT Question - BASG 11-Feb-2025Question - BASGGAUTN.A.Other
USA Recognized Consensus Standards N.A.Recognized Consensus StandardsGUSACurrentCorpus of texts
USA Recognized Consensus Standards - ISO 14155 21-Dec-2020Recognized Consensus Standards - ISO 14155GUSACurrentOfficial recommendation
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017Recommendations of the expert group - Risk proportionate approaches in clinical trialsHMEUCurrentOfficial recommendation
EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023Regulation (EC) No 1223/2009 - Cosmetic ProductsGEU ; GBRCurrentLegal act
EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022Regulation (EC) No 178/2002 - Food SafetyGEU ; GBRCurrentLegal act
EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human useNISEUCurrentLegal act
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016Regulation (EU) 2016/679 (GDPR)GEUCurrentLegal act
EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 PreambleRegulation (EU) 2017/745 - Medical Device RegulationMDEUN.A.Preamble of legal act
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023Regulation (EU) 2017/745 - Medical Device RegulationMDEUCurrentLegal act
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 PreambleRegulation (EU) 2017/746 - in vitro diagnostic medical devicesIVDEUN.A.Preamble of legal act
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023Regulation (EU) 2017/746 - in vitro diagnostic medical devicesIVDEUCurrentLegal act
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022Regulation (EU) 536/2014 - clinical trialsHMEUCurrentLegal act
EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 PreambleRegulation (EU) 536/2014 - clinical trialsHMEUN.A.Preamble of legal act
EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014Regulation (EU) 910/2014 - electronic identificationGEUCurrentLegal act
EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12Regulation (EU) No 520/2012 - performance of pharmacovigilance activitiesGEUCurrentRegulatory requirement
DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. undRichtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und BundesärztekammerGDEUCurrentInformation from official body
DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988SGB V

-

Sozialgesetzbuch Fünftes Buch		NISDEUCurrentLegal act
FRA SI RIPH 2G - Website 16-May-2025SI RIPH 2G - WebsiteMDFRACurrentInformation from official body
SMW TestSMW Test DocumentTESTCurrent
N.A. SPIRIT 2013 - Chan et al. 2013SPIRIT 2013 - Chan et al.GN.A.N.A.Litterature article
FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025SURV_VIG_DOC118 V01 REC-Avis aux promoteurs -Partie VHMFRACurrentOfficial recommendation
DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022StrlSchG - StrahlenschutzgesetzOtherDEUCurrentLegal act
DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021StrlSchV - StrahlenschutzverordnungOtherDEUCurrentRegulatory requirement
DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024TAMG - TierarzneimittelgesetzOtherDEUCurrentLegal act
GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019GGBRCurrentLegal act
GBR The Human Medicines Regulations 2012 01-Jan-2025The Human Medicines Regulations 2012HMGBRCurrentLegal act
GBR The Medical Devices Regulations 2002 11-Feb-2021The Medical Devices Regulations 2002MDGBRCurrentLegal act
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004The Medicines for Human Use (Clinical Trials) Regulations 2004HMGBRCurrentLegal act
N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025Transcelerate GCP mutual recognition programm FAQHMN.A.CurrentOther
USA U.S. Code Title 21 30-Sep-2023U.S. Code Title 21GUSACurrentLegal act
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020UK GDPR - United Kingdom General Data Protection RegulationGGBRCurrentLegal act
USA WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591 46114WARNING LETTER - Purolea Cosmetics Lab MARCS-CMS 722591GUSAN.A.Information from official body
WHO WHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONS Forty-fifth reportWHO - EXPERT COMMITTEE ON SPECIFICATIONS FOR PHARMACEUTICAL PREPARATIONSGWHON.A.Other
WHO WHO - Guidance for best practices for clinical trials 2024WHO - Guidance for best practices for clinical trialsGWHOCurrentInternational guideline
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995WHO - Guidelines for GCP for trials on pharmaceutical products*HMWHOCurrentInternational guideline
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005WHO - HANDBOOK

FOR GOOD CLINICAL RESEARCH PRACTICE

(GCP)		HMWHOCurrentInternational guideline
WHO WHO - ICD 11WHO - ICDHMWHOCurrentInternational guideline
WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026WHO Good Practices for Clinical Trial Design and ImplementationHMWHOCurrentOther
WHO World Health Organization -World Health OrganizationHMWHON.A.Corpus of texts
AUT Ärztegesetz 08-Mar-2023ÄrztegesetzGAUTCurrentLegal act

By status

Current

 Document nameScopeRegionType
EU 2011/C 172/01 - CT-3 11-Jun-20112011/C 172/01 - CT-3GEURegulatory requirement
USA 21 CFR Part 11 09-Apr-202521 CFR Part 11GUSALegal act
USA 21 CFR Part 312 09-Apr-202521 CFR Part 312HMUSALegal act
USA 21 CFR Part 314 09-Apr-202521 CFR Part 314HMUSALegal act
USA 21 CFR Part 320 09-Apr-202521 CFR Part 320HMUSALegal act
USA 21 CFR Part 50 09-Apr-202521 CFR Part 50GUSALegal act
USA 21 CFR Part 54 09-Apr-202521 CFR Part 54GUSALegal act
USA 21 CFR Part 56 09-Apr-202521 CFR Part 56GUSALegal act
USA 21 CFR Part 809 06-May-202421 CFR Part 809GUSALegal act
USA 21 CFR Part 812 09-Apr-202521 CFR Part 812MDUSALegal act
USA 42 CFR Part 11 09-Apr-202542 CFR Part 11GUSALegal act
USA 45 CFR Part 160 09-Apr-202545 CFR Part 160GUSALegal act
USA 45 CFR Part 46 09-Apr-202545 CFR Part 46GUSALegal act
FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025AEC-DM-DMDIV_DOC006 v04 AAP_RDM_Partie II_Modalités pratiquesMDFRAOfficial recommendation
FRA AEC DOC010 V.04 01-Jun-2018AEC_DOC010 V.04HMFRAOfficial recommendation
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie IIMDFRAOfficial recommendation
DEU AMG - Arzneimittelgesetz 19-Jul-2023AMG - ArzneimittelgesetzHM ; NIS ; OtherDEULegal act
AUT AMG – Arzneimittelgesetz 04-Mar-2023AMG – ArzneimittelgesetzHMAUTLegal act
DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnungMD ; HMDEURegulatory requirement
AUT AVG – Allgemeines Verwaltungsverfahrens-gesetz 23-Nov-2021AVG – Allgemeines Verwaltungsverfahrens-gesetzGAUTLegal act
USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018Acceptance of Clinical Data to Support

Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and

Food and Drug Administration Staff		MDUSAOfficial recommendation
DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023BGB - Bürgerliches GesetzbuchOtherDEULegal act
FRA Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL) 16-May-2024Bonnes pratiques - CONTRÔLE QUALITÉ À DISTANCE DES ESSAIS CLINIQUES (CNIL)GFRAOfficial recommendation
DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und FormOtherDEURegulatory requirement
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016CIOMS - International Ethical

Guidelines for Health-related Research

Involving Humans		GCIOMSInternational guideline
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016CIOMS - International Ethical Guidelines for Biomedical Research Involving Human SubjectsGCIOMSInternational guideline
EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022COMMISSION IMPLEMENTING DECISION (EU) 2022/729MD ; IVDEURegulatory requirement
USA CTCAE - Common Terminology Criteria for Adverse Events v5.0 (2017)CTCAE - Common Terminology Criteria for Adverse EventsGUSAOfficial recommendation
GBR Clinical Trial toolkit 28-Jan-2025Clinical Trial toolkitGGBRInformation from official body
GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021Clinical investigations of medical devices – compiling a submission to MHRAMDGBROfficial recommendation
FRA Code de la Santé Publique - Partie Réglementaire - 1ere partie, Livre 1er, Titre II 16-May-2025Code de la Santé Publique

- Partie Réglementaire -

1ere partie, Livre 1er, Titre II		GFRALegal act
FRA Code de la Santé Publique - Partie législative - 1ere partie, Livre 1er, Titre II 16-May-2025Code de la Santé Publique

- Partie législative -

1ere partie, Livre 1er, Titre II		GFRALegal act
FRA Constitution du 4 octobre 1958 10-Mar-2024Constitution du 4 octobre 1958GFRALegal act
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018DGEPi - GEP Guter Epidemiologischer PraxisNISDEUOfficial recommendation
FRA DHOS/E1/DAF/DPACI no 2007-322 14-Aug-2007DHOS/E1/DAF/DPACI no 2007-322GFRARegulatory requirement
GBR Data Protection Act 2018 06-Jun-2022Data Protection Act 2018GGBRLegal act
WMA Declaration of Helsinki 2024Declaration of HelsinkiGWMAInternational guideline
DEU Deutsches Ärzteblatt 45849Deutsches ÄrzteblattGDEUInformation from official body
GBR Directive 2001/20/EC 04-Apr-2001Directive 2001/20/ECHMGBRLegal act
EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12Directive 2001/83/EC - Community code relating to medicinal products for human useNISEURegulatory requirement
GBR Directive 90/385/EEC 05-Sep-2007Directive 90/385/EECMDGBRLegal act
GBR Directive 93/42/EEC 11-Oct-2007Directive 93/42/EECMDGBRLegal act
GBR Directive 98/79/EC 20-Dec-2011Directive 98/79/ECIVDGBRLegal act
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022EMA/298712/2022 - Complex clinical trials – Questions and answersHMEUInformation from official body
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator siteGEUOfficial guideline
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021EMA/698382/2021

- Guideline for the notification of serious breaches of

Regulation (EU) No 536/2014 or the clinical trial protocol		GEUOfficial guideline
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022EMA/786433/2022

Annex V – to guidance for the conduct of good clinical practice inspections – Phase I

units		GEUOfficial guideline
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023EMA/INS/GCP/112288/2023

- Guideline on computerised systems and electronic data in

clinical trials		GEUOfficial guideline
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023EMA/INS/GCP/126568/2023

- Annual Report of the Good Clinical Practice (GCP)

Inspectors' Working Group (IWG) 2022		GEUOfficial guideline
EU EMA/INS/GCP/143492/2022 - ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP: INVESTIGATOR SITE 2022EMA/INS/GCP/143492/2022

- ANNEX I TO PROCEDURE FOR CONDUCTING GCP INSPECTIONS REQUESTED BY THE CHMP:

INVESTIGATOR SITE		GEUOfficial guideline
EU EMA/INS/GCP/856758/ 2018 Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic) 06-Dec-2018EMA/INS/GCP/856758/ 2018

Guideline on the content, management and archiving of

the clinical trial master file (paper and/or electronic)		GEUOfficial guideline
EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005EMEA/CHMP/313666/2005

- GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY:

NEED FOR POST-AUTHORISATION DATA		HMEUOfficial guideline
EU ENCePP - Guide on Methodological Standards in Pharmacoepidemiology Revision 11 (2023)ENCePP - Guide on Methodological Standards in PharmacoepidemiologyINSEUOfficial recommendation
DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19GDEUOfficial recommendation
EU EudraLex – Volume 10 -EudraLex – Volume 10HMEUCorpus of texts
EUR European Bioethics Convention 1997European Bioethics ConventionGEURInternational treaty
EU European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025 45838European Medicines Agency’s Data Protection: Notice For Microsoft (MS) Copilot 365 - EMA pilot phase ; EMA/216030/2025GEUInformation from official body
USA Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review Procedure 1998Expedited Review: Categories of Research that may be Reviewed Through an Expedited Review ProcedureGUSAOfficial recommendation
USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023FD&C Act - Federal Food, Drug, and Cosmetic ActMD ; OtherUSALegal act
USA FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for Industry March 2018FDA - E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1): Guidance for IndustryGUSAOfficial recommendation
USA FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects Oct-2009FDA Guidance for Industry Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study SubjectsGUSAOfficial recommendation
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Trials 13-Apr-2015FDA Guidance for Industry -

Computerized Systems Used in

Clinical Trials		GUSAOfficial recommendation
USA FDA Guidance for Industry - Computerized Systems Used in Clinical Investigations May-2007FDA Guidance for Industry -

Computerized Systems Used in

Clinical Investigations		GUSAOfficial recommendation
USA FDA Guidance for Industry - Electronic Source Data in Clinical Investigations Sep-2013FDA Guidance for Industry - Electronic Source Data in Clinical InvestigationsGUSAOfficial recommendation
USA FDA Guidance for Industry - Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring Aug-2013FDA Guidance for Industry -

Oversight of Clinical Investigations —

A Risk-Based Approach to Monitoring		GUSAOfficial recommendation
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998FDA INFORMATION SHEET -

Recruiting Study Subjects,

Guidance for Institutional Review Boards and Clinical Investigators		HMUSAOfficial recommendation
USA FDA Information - Observations and citations 20-Mar-2024FDA Information - Observations and citationsGUSAInformation from official body
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOLHMGBROfficial guideline
EU GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMIC v5 10-Feb-2022GUIDANCE ON THE MANAGEMENT OF CLINICAL TRIALS DURING THE COVID-19 (CORONAVIRUS) PANDEMICGEUOfficial recommendation
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)GVP: Module VIII EMA/813938/2011NISEUOfficial guideline
EU GVP: Module XVI EMA/204715/2012 Rev. 3 (2024)GVP: Module XVI EMA/204715/2012GEUOfficial guideline
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studienNISDEUOfficial recommendation
GBR Guidance Access to Electronic Health Records by Sponsor representatives in clinical trials 44447Guidance Access to Electronic Health Records by Sponsor representatives in clinical trialsGGBROfficial recommendation
GBR Guidance Managing clinical trials during Coronavirus (COVID-19) 16-Nov-.2021Guidance Managing clinical trials during Coronavirus (COVID-19)GGBROfficial recommendation
GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015Guidance - Good clinical practice for clinical trialsHMGBROfficial recommendation
FRA Guide de légistique 07-Feb-2024Guide de légistiqueGFRAInformation from official body
GBR HRA - Ending your project 28-Jan-2025HRA - Ending your projectGGBROfficial recommendation
ICH ICH E11 Guideline R1 (2017)ICH E11 GuidelineGICHInternational guideline
ICH ICH E19 Guideline 2022ICH E19 GuidelineGICHInternational guideline
ICH ICH E2A Guideline 1994ICH E2A GuidelineGICHInternational guideline
ICH ICH E2F Guideline 2010ICH E2F GuidelineGICHInternational guideline
ICH ICH E3 Guideline 1995ICH E3 GuidelineGICHInternational guideline
ICH ICH E6 Guideline R3 (2025)ICH E6 GuidelineHMICHInternational guideline
ICH ICH E7 Guideline 1993ICH E7 GuidelineGICHInternational guideline
ICH ICH E8 Guideline R1 (2021)ICH E8 GuidelineHMICHInternational guideline
ICH ICH E9 Guideline 1998ICH E9 GuidelineHMICHInternational guideline
ICH ICH E9 Guideline - Addendum R1 20-Nov-2019ICH E9 Guideline - Addendum R1HMICHInternational guideline
EU INS/GCP/46309/2012 - Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP 2012INS/GCP/46309/2012

- Classification and analysis of the GCP inspection findings

of GCP inspections conducted at the request of the CHMP		GEUInformation from official body
GBR IRAS - Integrated Research Application System 28-Jan-2025IRAS - Integrated Research Application SystemGGBRInformation from official body
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020ISO 14155 - Clinical investigation of medical devices for human subjectsMDISOInternational guideline
INT ISPE - GPP Revision 3 (2015)ISPE - GPPINSINTInternational guideline
FRA Infographie - La hiérarchie des normes 22-Mar-2024Infographie - La hiérarchie des normesGFRAInformation from official body
USA Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and Sponsors Aug-2023Informed Consent - FDA Guidance for IRBs, Clinical Investigators, and SponsorsGUSAOfficial recommendation
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022KPBV - Klinische Prüfung-Bewertungsverfahren-VerordnungHMDEURegulatory requirement
AUT LekV – Leit-Ethikkommissions-Verordnung 29-Nov-2024LekV – Leit-Ethikkommissions-VerordnungGAUTRegulatory requirement
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021MBO - Berufsordnung der Ärzt:innenGDEURegulatory requirement
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020MDCG 2020-10/1

- Safety reporting in clinical investigations

of medical devices		MDEU ; GBROfficial recommendation
GBR MEDDEV 2.7/3 revision 3 May-2015MEDDEV 2.7/3 revision 3MDGBROfficial guideline
GBR MHRA GCP Inspection Dossier template V7.0MHRA GCP Inspection Dossier templateGGBRInformation from official body
DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021MPAMIV - Medizinprodukte-Anwendermelde- und InformationsverordnungMDDEURegulatory requirement
DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021MPBetreibV - Medizinprodukte-BetreiberverordnungMDDEURegulatory requirement
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MPDG - Medizinprodukterecht-DurchführungsgesetzMD ; IVDDEULegal act
AUT MPG – Medizinproduktegesetz 26-May-2022MPG – MedizinproduktegesetzMDAUTLegal act
GBR Making changes to a research study to manage the impact of COVID-19 12-Oct-2021Making changes to a research study to manage the impact of COVID-19GGBROfficial recommendation
GBR Medicines and Medical Devices Act 2021 21-Feb-2021Medicines and Medical Devices Act 2021GGBRLegal act
N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel TrainingHMN.A.Other
USA NCI GUIDELINES FOR INVESTIGATORS: ADVERSE EVENT REPORTING REQUIREMENTS FOR DCTD (CTEP AND CIP) INDs AND IDEs 30-Aug-2024NCI GUIDELINES FOR INVESTIGATORS:

ADVERSE EVENT REPORTING REQUIREMENTS

FOR DCTD (CTEP AND CIP) INDs AND IDEs		GUSAOther
GBR NHS: Records Management Code of Practice 07-Aug-2023NHS: Records Management Code of PracticeGGBRRegulatory requirement
USA NIH - SCORE Manual N.A.NIH - SCORE ManualGUSACorpus of texts
USA NIH - SCORE Manual: Appendix Source Documents Requirements Rev 01 16-Aug-2025NIH - SCORE Manual: Appendix Source Documents RequirementsGUSAOfficial recommendation
USA NIH - Glossary 27-May-2025NIH - GlossaryNISUSAInformation from official body
GBR NIHR - National Institute for Health and Care Research 28-Jan-2025NIHR - National Institute for Health and Care ResearchGGBRInformation from official body
GBR National Health Service Act 2006 02-Dec-2019National Health Service Act 2006GGBRLegal act
USA Recognized Consensus Standards N.A.Recognized Consensus StandardsGUSACorpus of texts
USA Recognized Consensus Standards - ISO 14155 21-Dec-2020Recognized Consensus Standards - ISO 14155GUSAOfficial recommendation
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017Recommendations of the expert group - Risk proportionate approaches in clinical trialsHMEUOfficial recommendation
EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023Regulation (EC) No 1223/2009 - Cosmetic ProductsGEU ; GBRLegal act
EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022Regulation (EC) No 178/2002 - Food SafetyGEU ; GBRLegal act
EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human useNISEULegal act
EU Regulation (EU) 2016/679 (GDPR) 04-May-2016Regulation (EU) 2016/679 (GDPR)GEULegal act
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023Regulation (EU) 2017/745 - Medical Device RegulationMDEULegal act
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023Regulation (EU) 2017/746 - in vitro diagnostic medical devicesIVDEULegal act
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022Regulation (EU) 536/2014 - clinical trialsHMEULegal act
EU Regulation (EU) 910/2014 - electronic identification 17-Sep-2014Regulation (EU) 910/2014 - electronic identificationGEULegal act
EU Regulation (EU) No 520/2012 - performance of pharmacovigilance activities 20-Jun-12Regulation (EU) No 520/2012 - performance of pharmacovigilance activitiesGEURegulatory requirement
DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. undRichtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. und BundesärztekammerGDEUInformation from official body
DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988SGB V

-

Sozialgesetzbuch Fünftes Buch		NISDEULegal act
FRA SI RIPH 2G - Website 16-May-2025SI RIPH 2G - WebsiteMDFRAInformation from official body
SMW TestSMW Test DocumentTEST
FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025SURV_VIG_DOC118 V01 REC-Avis aux promoteurs -Partie VHMFRAOfficial recommendation
DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022StrlSchG - StrahlenschutzgesetzOtherDEULegal act
DEU StrlSchV - Strahlenschutzverordnung 08-Oct-2021StrlSchV - StrahlenschutzverordnungOtherDEURegulatory requirement
DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024TAMG - TierarzneimittelgesetzOtherDEULegal act
GBR The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019 23-Jan-2019The Electronic Identification and Trust Services for Electronic Transactions (Amendment etc.) (EU Exit) Regulations 2019GGBRLegal act
GBR The Human Medicines Regulations 2012 01-Jan-2025The Human Medicines Regulations 2012HMGBRLegal act
GBR The Medical Devices Regulations 2002 11-Feb-2021The Medical Devices Regulations 2002MDGBRLegal act
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004The Medicines for Human Use (Clinical Trials) Regulations 2004HMGBRLegal act
N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025Transcelerate GCP mutual recognition programm FAQHMN.A.Other
USA U.S. Code Title 21 30-Sep-2023U.S. Code Title 21GUSALegal act
GBR UK GDPR - United Kingdom General Data Protection Regulation 31-Dec-2020UK GDPR - United Kingdom General Data Protection RegulationGGBRLegal act
WHO WHO - Guidance for best practices for clinical trials 2024WHO - Guidance for best practices for clinical trialsGWHOInternational guideline
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995WHO - Guidelines for GCP for trials on pharmaceutical products*HMWHOInternational guideline
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005WHO - HANDBOOK

FOR GOOD CLINICAL RESEARCH PRACTICE

(GCP)		HMWHOInternational guideline
WHO WHO - ICD 11WHO - ICDHMWHOInternational guideline
WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026WHO Good Practices for Clinical Trial Design and ImplementationHMWHOOther
AUT Ärztegesetz 08-Mar-2023ÄrztegesetzGAUTLegal act

Draft

 Document nameScopeRegion
ICH ICH E6 Guideline - Annex 2 R3 Annex 2ICH E6 Guideline - Annex 2HMICH

Superseded

By scope

Human Medicines (HM)

 Document nameStatusRegion
USA 21 CFR Part 312 09-Apr-202521 CFR Part 312CurrentUSA
USA 21 CFR Part 314 09-Apr-202521 CFR Part 314CurrentUSA
USA 21 CFR Part 320 09-Apr-202521 CFR Part 320CurrentUSA
FRA AEC DOC010 V.04 01-Jun-2018AEC_DOC010 V.04CurrentFRA
DEU AMG - Arzneimittelgesetz 19-Jul-2023AMG - ArzneimittelgesetzCurrentDEU
AUT AMG – Arzneimittelgesetz 04-Mar-2023AMG – ArzneimittelgesetzCurrentAUT
DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnungCurrentDEU
EU CHMP Guidelines -CHMP GuidelinesN.A.EU
GBR Directive 2001/20/EC 04-Apr-2001Directive 2001/20/ECCurrentGBR
EU EMA Guidelines -EMA GuidelinesN.A.EU
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022EMA/298712/2022 - Complex clinical trials – Questions and answersCurrentEU
EU EMEA/CHMP/313666/2005 - GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY: NEED FOR POST-AUTHORISATION DATA 14-Nov-2005EMEA/CHMP/313666/2005

- GUIDELINE ON THE EXPOSURE TO MEDICINAL PRODUCTS DURING PREGNANCY:

NEED FOR POST-AUTHORISATION DATA		CurrentEU
EU EudraLex – Volume 10 -EudraLex – Volume 10CurrentEU
USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998FDA INFORMATION SHEET -

Recruiting Study Subjects,

Guidance for Institutional Review Boards and Clinical Investigators		CurrentUSA
GBR GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOL 08-Jul-2020GUIDANCE FOR THE NOTIFICATION OF SERIOUS BREACHES OF GCP OR THE TRIAL PROTOCOLCurrentGBR
GBR Guidance - Good clinical practice for clinical trials 16-Oct-2015Guidance - Good clinical practice for clinical trialsCurrentGBR
ICH ICH E6 Guideline R3 (2025)ICH E6 GuidelineCurrentICH
ICH ICH E6 Guideline - Annex 2 R3 Annex 2ICH E6 Guideline - Annex 2DraftICH
ICH ICH E8 Guideline R1 (2021)ICH E8 GuidelineCurrentICH
ICH ICH E9 Guideline 1998ICH E9 GuidelineCurrentICH
ICH ICH E9 Guideline - Addendum R1 20-Nov-2019ICH E9 Guideline - Addendum R1CurrentICH
ICH ICH Guidelines -ICH GuidelinesN.A.ICH
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022KPBV - Klinische Prüfung-Bewertungsverfahren-VerordnungCurrentDEU
N.A. Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel Training V3.0Minimum Criteria for ICH E6 (R3) GCP Investigator Site Personnel TrainingCurrentN.A.
EU Recommendations of the expert group - Risk proportionate approaches in clinical trials 25-Apr-2017Recommendations of the expert group - Risk proportionate approaches in clinical trialsCurrentEU
EU Regulation (EU) 536/2014 - clinical trials 27-May-2014 PreambleRegulation (EU) 536/2014 - clinical trialsN.A.EU
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022Regulation (EU) 536/2014 - clinical trialsCurrentEU
FRA SURV VIG DOC118 V01 REC-Avis aux promoteurs -Partie V 16-May-2025SURV_VIG_DOC118 V01 REC-Avis aux promoteurs -Partie VCurrentFRA
GBR The Human Medicines Regulations 2012 01-Jan-2025The Human Medicines Regulations 2012CurrentGBR
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004The Medicines for Human Use (Clinical Trials) Regulations 2004CurrentGBR
N.A. Transcelerate GCP mutual recognition programm FAQ 21-May-2025Transcelerate GCP mutual recognition programm FAQCurrentN.A.
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995WHO - Guidelines for GCP for trials on pharmaceutical products*CurrentWHO
WHO WHO - HANDBOOK FOR GOOD CLINICAL RESEARCH PRACTICE (GCP) 2005WHO - HANDBOOK

FOR GOOD CLINICAL RESEARCH PRACTICE

(GCP)		CurrentWHO
WHO WHO - ICD 11WHO - ICDCurrentWHO
WHO WHO Good Practices for Clinical Trial Design and Implementation 04-May-2026WHO Good Practices for Clinical Trial Design and ImplementationCurrentWHO
WHO World Health Organization -World Health OrganizationN.A.WHO

Medical Devices (MD)

 Document nameStatusRegion
USA 21 CFR Part 812 09-Apr-202521 CFR Part 812CurrentUSA
FRA AEC-DM-DMDIV DOC006 v04 AAP RDM Partie II Modalités pratiques 16-May-2025AEC-DM-DMDIV_DOC006 v04 AAP_RDM_Partie II_Modalités pratiquesCurrentFRA
FRA AEC DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie II 16-May-2025AEC_DOC012 v03 Avis aux promoteurs d’investigations cliniques de DM (RIPH1) – Partie IICurrentFRA
DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnungCurrentDEU
USA Acceptance of Clinical Data to Support Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and Food and Drug Administration Staff 21-Feb-2018Acceptance of Clinical Data to Support

Medical Device Applications and Submissions Frequently Asked Questions - Guidance for Industry and

Food and Drug Administration Staff		CurrentUSA
EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022COMMISSION IMPLEMENTING DECISION (EU) 2022/729CurrentEU
GBR Clinical investigations of medical devices – compiling a submission to MHRA May 2021Clinical investigations of medical devices – compiling a submission to MHRACurrentGBR
GBR Directive 90/385/EEC 05-Sep-2007Directive 90/385/EECCurrentGBR
GBR Directive 93/42/EEC 11-Oct-2007Directive 93/42/EECCurrentGBR
USA FD&C Act - Federal Food, Drug, and Cosmetic Act 30-Sep-2023FD&C Act - Federal Food, Drug, and Cosmetic ActCurrentUSA
IMDRF IMDRF – Guidelines -IMDRF – GuidelinesN.A.IMDRF
ISO ISO 14155 - Clinical investigation of medical devices for human subjects 2020ISO 14155 - Clinical investigation of medical devices for human subjectsCurrentISO
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020MDCG 2020-10/1

- Safety reporting in clinical investigations

of medical devices		CurrentEU ; GBR
EU MDCG Guidelines -MDCG GuidelinesN.A.EU
GBR MEDDEV 2.7/3 revision 3 May-2015MEDDEV 2.7/3 revision 3CurrentGBR
DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021MPAMIV - Medizinprodukte-Anwendermelde- und InformationsverordnungCurrentDEU
DEU MPBetreibV - Medizinprodukte-Betreiberverordnung 24-Apr-2021MPBetreibV - Medizinprodukte-BetreiberverordnungCurrentDEU
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MPDG - Medizinprodukterecht-DurchführungsgesetzCurrentDEU
AUT MPG – Medizinproduktegesetz 26-May-2022MPG – MedizinproduktegesetzCurrentAUT
EU Regulation (EU) 2017/745 - Medical Device Regulation 20-Mar-2023Regulation (EU) 2017/745 - Medical Device RegulationCurrentEU
EU Regulation (EU) 2017/745 - Medical Device Regulation 05-May-2017 PreambleRegulation (EU) 2017/745 - Medical Device RegulationN.A.EU
FRA SI RIPH 2G - Website 16-May-2025SI RIPH 2G - WebsiteCurrentFRA
GBR The Medical Devices Regulations 2002 11-Feb-2021The Medical Devices Regulations 2002CurrentGBR

In Vitro Diagnostics (IVD)

 Document nameStatusRegion
EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022COMMISSION IMPLEMENTING DECISION (EU) 2022/729CurrentEU
GBR Directive 98/79/EC 20-Dec-2011Directive 98/79/ECCurrentGBR
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MPDG - Medizinprodukterecht-DurchführungsgesetzCurrentDEU
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 05-May-2017 PreambleRegulation (EU) 2017/746 - in vitro diagnostic medical devicesN.A.EU
EU Regulation (EU) 2017/746 - in vitro diagnostic medical devices 20-Mar-2023Regulation (EU) 2017/746 - in vitro diagnostic medical devicesCurrentEU

GMP / PV / NIS

 Document nameScopeStatus
DEU AMG - Arzneimittelgesetz 19-Jul-2023AMG - ArzneimittelgesetzHM ; NIS ; OtherCurrent
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018DGEPi - GEP Guter Epidemiologischer PraxisNISCurrent
EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12Directive 2001/83/EC - Community code relating to medicinal products for human useNISCurrent
EU GVP: Module VIII EMA/813938/2011 Rev. 3 (2017)GVP: Module VIII EMA/813938/2011NISCurrent
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studienNISCurrent
USA NIH - Glossary 27-May-2025NIH - GlossaryNISCurrent
EU Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human use 28-Jan-22Regulation (EC) No 726/2004 - authorisation and supervision of medicinal products for human useNISCurrent
DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988SGB V

-

Sozialgesetzbuch Fünftes Buch		NISCurrent

References

 DocumentScopeLanguage
AUT BASG - FAQ 11-Feb-2025 SchwarzAUT BASG - FAQ 11-Feb-2025GDE
AUT BASG - FAQ 11-Feb-2025 Änderung am PersonalAUT BASG - FAQ 11-Feb-2025GDE
AUT FAQ - COVID-19 Studien 15-Mar-2021 -AUT FAQ - COVID-19 Studien 15-Mar-2021GDE
AUT MPG – Medizinproduktegesetz 26-May-2022 § 22AUT MPG – Medizinproduktegesetz 26-May-2022MDDE
AUT Question - BASG 11-Feb-2025 -AUT Question - BASG 11-Feb-2025GDE
AUT Ärztegesetz 08-Mar-2023 § 51 (3)AUT Ärztegesetz 08-Mar-2023GDE
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 23CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016GEN
CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016 Page 20CIOMS CIOMS - International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016GEN
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 19CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016GEN
CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016 GUIDELINE 18CIOMS CIOMS - International Ethical Guidelines for Health-related Research Involving Humans 2016GEN
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-001DEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41cDEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40aDEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40DEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41bDEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41aDEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 77DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-002DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3a–4DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 3DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 2 Absatz 1 – 2DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (3)DEU AMG - Arzneimittelgesetz 19-Jul-2023NISDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 3DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 g Absatz 1 – 2DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 23DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63 f Absatz 1 – 3DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 34DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42aDEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 1DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 2DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 25DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-001DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 96 Nr. 10, 11, 21DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 3DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 4DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 5DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-001DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 41DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b-002DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 4 Absatz 24DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40 Absatz 2DEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6)DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63gDEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40c-001DEU AMG - Arzneimittelgesetz 19-Jul-2023GDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63fDEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (1) ; (6)DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-003DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40b Absatz 6-002DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40a Absatz 3DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 40d-002DEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42bDEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63f (4)DEU AMG - Arzneimittelgesetz 19-Jul-2023NISDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 63g (4)DEU AMG - Arzneimittelgesetz 19-Jul-2023NISDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 67 (6) - NISDEU AMG - Arzneimittelgesetz 19-Jul-2023NISDE
DEU AMG - Arzneimittelgesetz 19-Jul-2023 § 42cDEU AMG - Arzneimittelgesetz 19-Jul-2023HMDE
DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019 § 20DEU AMWHV – Arzneimittel- und Wirkstoffherstellungs-verordnung 09-Aug-2019HMDE
DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023 § 630DEU BGB - Bürgerliches Gesetzbuch 22-Dec-2023GDE
DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021 -DEU Bundestag - Sachstand zur Aufbewahrung von Patientenakten in der ambulanten Praxis Fristen und Form 01-Mar-2021GDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8 8.4DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 10DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 11DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 8DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.2DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 5DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 4DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.9DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.3DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.10DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.5 - 6.7DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.7DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 7DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 2DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 3 3.3 - 3.6DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.1DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.4DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 1 1.1 ; 1.3DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 9DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018 Leitlinie 6 6.8DEU DGEPi - GEP Guter Epidemiologischer Praxis Sep-2018NISDE
DEU Deutsches Ärzteblatt 45849 -DEU Deutsches Ärzteblatt 45849GDE
DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021 -DEU Empfehlungen des BfArM und des PEI zur Europäischen Guidance during COVID-19 v4 04-Feb-2021GDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.4DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.3DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.1DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-002DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.1DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.2DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.1-001DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.7DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.3DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 3.2DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.5DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.4DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - EndeDEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 1.3DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.3DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.2.1 - StartDEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022 2.7.6DEU Gemeinsame Empfehlungen - zur Anzeige von Anwendungsbeobachtungen und nichtinterventionellen Unbedenklichkeits-studien 15-Dec-2022NISDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 11DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 8DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 6DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 4DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 5DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 9DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 7DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022 § 10DEU KPBV - Klinische Prüfung-Bewertungsverfahren-Verordnung 31-Jan-2022GDE
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 33DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021GDE
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 15DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021GDE
DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021 § 10 Absatz 3DEU MBO - Berufsordnung der Ärzt:innen 11-Jun-2021GDE
DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021 § 2DEU MPAMIV - Medizinprodukte-Anwendermelde- und Informationsverordnung 21-Apr-2021MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 79DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-003DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 26DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 77DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 66DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 68DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64 Absatz 3DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 64DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 63DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-002DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 50DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 4DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 54DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 38DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 53DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31bDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022IVDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 49DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-001DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-002DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 42DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 41DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 40DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 55DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 39DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 59DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 1 – 2DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 65DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 62-001DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31aDEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022IVDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 3 Absatz 5 – 6DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 3DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 28 Absatz 4 – 6DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 30-001DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 85DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 47-002DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 33 Absatz 2DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 6DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 48DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 35DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022 § 31DEU MPDG - Medizinprodukterecht-Durchführungsgesetz 28-Jun-2022MDDE
DEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. undDEU Richtlinie zur Bewertung der Qualifikation von Prüfern, Hauptprüfern, Leitern und ärztlichen Mitgliedern von Prüfungsteams durch Ethik-Kommissionen von Arbeitskreis Medizinischer Ethik-Kommissionen in der Bundesrepublik Deutschland e. V. undGDE
DEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988 § 35aDEU SGB V - Sozialgesetzbuch Fünftes Buch 20-Dez-1988NISDE
DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022 § 32DEU StrlSchG - Strahlenschutzgesetz 03-Jan-2022GDE
DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024 § 65DEU TAMG - Tierarzneimittelgesetz 14-Mar-2024MDDE
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.1EU 2011/C 172/01 - CT-3 11-Jun-2011GEN
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.3EU 2011/C 172/01 - CT-3 11-Jun-2011GEN
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2EU 2011/C 172/01 - CT-3 11-Jun-2011GEN
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-002EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020MDEN
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8-001EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020MDEN
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-002EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020MDEN
EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020 8.2-001EU ; GBR MDCG 2020-10/1 - Safety reporting in clinical investigations of medical devices 2020MDEN
EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023 Article 2EU ; GBR Regulation (EC) No 1223/2009 - Cosmetic Products 01-Dec-2023GEN
EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022 Article 2EU ; GBR Regulation (EC) No 178/2002 - Food Safety 01-Jul-2022GEN
EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (9)EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022MDEN
EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022 (8)EU COMMISSION IMPLEMENTING DECISION (EU) 2022/729 11-May-2022IVDEN
EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107nEU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12NISEN
EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12 Article 107m (1)EU Directive 2001/83/EC - Community code relating to medicinal products for human use 20-Jun-12NISEN
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 -EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022HMEN
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q1.2EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022HMEN
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 Q5.2EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022HMEN
EU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022 GlossaryEU EMA/298712/2022 - Complex clinical trials – Questions and answers 23-May-2022HMEN
EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017 4.EU EMA/431265/2016 Annex I – to guidance for the conduct of good clinical practice inspections – investigator site 06-Sep-2017GEN
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.1EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021GEN
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 6.4EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021GEN
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 3.2EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021GEN
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 5.1EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021GEN
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 4EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021GEN
EU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021 Appendix IEU EMA/698382/2021 - Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol 2021GEN
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-001EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022GEN
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.9EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022GEN
EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022 2.5-002EU EMA/786433/2022 Annex V – to guidance for the conduct of good clinical practice inspections – Phase I units 15-Nov-2022GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.2EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex A A5.3EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.8EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 A4.13EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.6EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 CCEATEU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.5 ALCOAEU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 4.4EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023 Annex 5 A5.2EU EMA/INS/GCP/112288/2023 - Guideline on computerised systems and electronic data in clinical trials 2023GEN
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - OrganisationEU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023GEN
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - RandomisationEU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023GEN
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - ComComplianceEU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023GEN
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - SDEU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023GEN
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 a)EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023GEN
EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 3.1.2 - MonitoringEU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023GEN
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