Glossary:TAG-00003-Adv-cht

Glossary > Adverse reaction

Adverse reaction
Tag-ID	TAG-00003-Adv-cht
English	Adverse reaction / Side effect
EN Abbr.	AR
French	Effet indésirable / Réaction indésirable
FR Abbr.	EI
German	Nebenwirkung / Unerwünschte Arzneimittelwirkung
DE Abbr.	NW / UAW

References

	Scope	Document part	Language	Document
EU 2011/C 172/01 - CT-3 11-Jun-2011 Section 7 7.3.2	G	Section 7 7.3.2	EN	EU 2011/C 172/01 - CT-3 11-Jun-2011
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (n)	HM	Article 2 (n)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR Directive 2001/20/EC 04-Apr-2001 Article 2 (p)	HM	Article 2 (p)	EN	GBR Directive 2001/20/EC 04-Apr-2001
GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004 Article 2 adverse event adverse reaction	HM	Article 2 adverse event adverse reaction	EN	GBR 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 Article 2 unexpected adverse reaction	HM	Article 2 unexpected adverse reaction	EN	GBR The Medicines for Human Use (Clinical Trials) Regulations 2004 01-May-2004
ICH ICH E2A Guideline 1994 II A. 3.	G	II A. 3.	EN	ICH ICH E2A Guideline 1994
ICH ICH E2A Guideline 1994 II B. Serious Adverse Event or Adverse Drug Reaction	G	II B. Serious Adverse Event or Adverse Drug Reaction	EN	ICH ICH E2A Guideline 1994
ICH ICH E2A Guideline 1994 III A. 1.	G	III A. 1.	EN	ICH ICH E2A Guideline 1994
ICH ICH E6 Guideline R3 (2025) GLOSSARY - Adverse Drug Reaction (ADR)	G	GLOSSARY - Adverse Drug Reaction (ADR)	EN	ICH ICH E6 Guideline R3 (2025)
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Life-threatening Adverse event	HM	§ 312.32 - Life-threatening Adverse event	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Suspected adverse reaction	HM	§ 312.32 - Suspected adverse reaction	EN	USA 21 CFR Part 312 09-Apr-2025
USA 21 CFR Part 312 09-Apr-2025 § 312.32 - Unexpected adverse event	HM	§ 312.32 - Unexpected adverse event	EN	USA 21 CFR Part 312 09-Apr-2025
WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995 Glossary - adverse reaction	HM	Glossary - adverse reaction	EN	WHO WHO - Guidelines for GCP for trials on pharmaceutical products* 1995