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Document:EU CHMP Guidelines -: Difference between revisions

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|DocDescription=The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.
 
Clinical efficacy and safety guideline categories :
- Alimentary tract and metabolism
- Blood and blood forming organs
- Blood products (including biotechnological alternatives)
- Cardiovascular system
- Dermatologicals
- Genito-urinary system and sex hormones
- Anti-infectives for systemic use
- Antineoplastic and immunomodulating agents
- Rheumatology/musculoskeletal system
- Nervous system
- Respiratory system
- Orally inhaled products
- Radiopharmaceuticals and diagnostic agents
- Allergy/Immunology
- Biostatistics
- General (Including ICH guidelines E1
 
To be noted:
- INS/GCP/46309/2012 – Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP
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|DocSubmittedBy=Florian Adragna
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Latest revision as of 12:54, 16 July 2026


Document information
Reference EU CHMP Guidelines -
Validity area EU
Scope(s) HM
Document name CHMP Guidelines
Version / Revision -
Status N.A.
Document type Corpus of texts
Language(s) EN
Description The Committee for Medicinal Products for Human Use (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines.

Clinical efficacy and safety guideline categories : - Alimentary tract and metabolism - Blood and blood forming organs - Blood products (including biotechnological alternatives) - Cardiovascular system - Dermatologicals - Genito-urinary system and sex hormones - Anti-infectives for systemic use - Antineoplastic and immunomodulating agents - Rheumatology/musculoskeletal system - Nervous system - Respiratory system - Orally inhaled products - Radiopharmaceuticals and diagnostic agents - Allergy/Immunology - Biostatistics - General (Including ICH guidelines E1

To be noted: - INS/GCP/46309/2012 – Classification and analysis of the GCP inspection findings of GCP inspections conducted at the request of the CHMP

Official source Official link
Restricted access No
Submitted by Florian Adragna
Contributors

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