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Glossary:TAG-00011-Inv-tud

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Glossary > Investigational drug (IMP)

Investigational drug (IMP)
Tag-ID TAG-00011-Inv-tud
English Investigational medicinal product / Investigational new drug / Investigational drug / Study drug / Test drug
EN Abbr. IMP / IND
French Médicament expérimental / Produit expérimental / Produit à l'étude / Médicament en cours d'investigation
FR Abbr. ME
German PrĂŒfprĂ€parat / PrĂŒfmedikament / PrĂŒfarzneimittel / Studienmedikament / Investigationelles Arzneimittel
DE Abbr. PP / IND

References

 ScopeDocument partLanguageDocument
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 51HMArticle 51ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 66HMArticle 66ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
EU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022 Article 68HMArticle 68ENEU Regulation (EU) 536/2014 - clinical trials 05-Dec-2022
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n)HMArticle 2 (n)ENGBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 investigational medicinal productHMArticle 2 investigational medicinal productENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Schedule 7 Part 2 2.HMSchedule 7

Part 2

2.		ENGBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3GAnnex 2 2.3ENICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline - Annex 2 R3 Annex 2 Annex 2 2.3.2GAnnex 2 2.3.2ENICH ICH E6 Guideline - Annex 2 R3 Annex 2
ICH ICH E6 Guideline R3 (2025) Appendix A 3.4GAppendix A 3.4ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Clinical TrialGGLOSSARY - Clinical TrialENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Investigational ProductGGLOSSARY - Investigational ProductENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 2.10GIII. Annex 1 2.10ENICH ICH E6 Guideline R3 (2025)
ICH ICH E6 Guideline R3 (2025) III. Annex 1 3.15GIII. Annex 1 3.15ENICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 312 09-Apr-2025 § 312.21HM§ 312.21ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (5)HM§ 312.23 (a) ; (5)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.23 (a) ; (6)HM§ 312.23 (a) ; (6)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.33 (a) - (b)HM§ 312.33 (a) - (b)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.40 (b)HM§ 312.40 (b)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.40 (c) (d)HM§ 312.40 (c) (d)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.45HM§ 312.45ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (b)HM§ 312.53 (b)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.53 (viii)HM§ 312.53 (viii)ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.6 - §312.8 ; § 312.10HM§ 312.6 - §312.8 ; § 312.10ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.61HM§ 312.61ENUSA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.69HM§ 312.69ENUSA 21 CFR Part 312 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.3HM10.3ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 10.4HM10.4ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 5.6HM5.6ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - clinical trialHMGlossary - clinical trialENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - investigational product (synonym: study product)HMGlossary - investigational product (synonym: study product)ENWHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995
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