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

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

{| class="wikitable gplx-infobox"
|-
! colspan="2" class="gplx-infobox-header" | Reference Details
|-
! Module
| Module 4 — Unit 4.5.2
|-
! Scope
| G
|-
! Document part
| 4.3
|-
! Language
| EN
|-
! Original entry by
| Florian Adragna
|-
! Contributors
| 
|-
! Tags
| [[Glossary:TAG-00044-Ins-ion|Inspection]], [[Glossary:TAG-00057-Com-deR|Competent authority]], [[Glossary:TAG-00043-Goo-tek|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.