Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3

Document information
Reference	EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023
Validity area	EU
Scope(s)	G
Document name	EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022
Version / Revision	2023
Status	Current
Document type	Official guideline
Language(s)	EN
Description	EMA/INS/GCP/164938/2024 Inspections Office Quality and Safety of Medicines Department Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2023 Adopted by the GCP IWG on 26 November 2024
Official source	Official link
Restricted access	No
Submitted by	Florian Adragna
Contributors

Reference Details
Module	Module 4 — Unit 4.5.2
Scope	G
Document part	4.3
Language	EN
Original entry by	Florian Adragna
Contributors
Tags	Inspection, Competent authority, Good clinical practice
Comment	Inspection cooperation between EU/EEA Member States

Content

4.3. Inspection cooperation

• Cooperation between the EU/EEA MSs: Nearly all the inspections conducted in 2022 were joint inspections involving inspectors from at least two MSs. Only two inspections were carried out by one MS only: in both cases, these were triggered inspections with a narrow scope, where one Member State was deemed enough for the purpose.

• Cooperation with third countries: Observers from countries outside the EU/EEA are systematically invited to observe the EU/EEA GCP inspections performed in those countries in the context of the centralised procedure. In 2022, inspectors from Argentina, China, Turkey, Switzerland, UK, and USA observed GCP inspections requested by the CHMP. In addition, one inspection was conducted jointly with the US FDA.