Reference:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 4.3: Difference between revisions
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| | |has_document=Document:EU EMA/INS/GCP/126568/2023 - Annual Report of the Good Clinical Practice (GCP) Inspectors' Working Group (IWG) 2022 2023 | ||
| | |module=4 | ||
| | |unit=4.5.2 | ||
| | |scope=G | ||
| | |doc_part=4.3 | ||
| | |language=EN | ||
|entry_by=Florian Adragna | |||
|contributors= | |||
|tags=TAG-00044-Ins-ion ++ TAG-00057-Com-deR ++ TAG-00043-Goo-tek | |||
|tags_display=[[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 | |||
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4.3. Inspection cooperation | |||
• Cooperation between the EU/EEA MSs: | • Cooperation between the EU/EEA MSs: | ||
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• Cooperation with third countries: | • 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. | 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. | ||
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Revision as of 12:56, 16 July 2026
| 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 |
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.
