Inspections procedure

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Recommendations and guidance related to the implementation of GCP

These recommendations and guidance documents are for the attention of sponsors, CROs, clinical investigators and other parties involved in the conduct of clinical trials. They have been prepared by the GCP Inspectors Working Group in conjunction, where needed, with other Working Groups and Committees of the European Regulatory Network.

Reflection Paper on advice to applicants / sponsors / CROs of Bioequivalence studies

Inspection procedures and guidance for GCP inspections conducted in the context of the Centralised Procedure

The GCP Inspectors Working Group has developed procedures for the coordination, preparation, conduct and reporting of GCP inspections carried out in the context of the Centralised Procedure.

These inspections are adopted by the CHMP and may be routine or may be triggered by issues arising during the assessment of the dossier or by other information such as previous inspection experience.

They are usually requested during the initial review of a Marketing Authorisation Application, but could arise post-authorisation (e.g. inspection of studies conducted or completed as part of the condition of a marketing authorisation, or because of concerns arising about the studies previously submitted).

Send all queries regarding this content to: gcp@ema.europa.eu

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Document(s) Language Status First published Last updated Effective Date
Guidance on triggers for inspections of bioequivalence trials (English only) adopted 2013-08-20    
Procedure for coordinating good-clinical-practice inspections requested by the CHMP (English only) adopted 2008-02-21 2014-05-23  
INS-GCP-2 procedure for preparing GCP inspections requested by the EMEA (English only) adopted 2007-09-20    
INS-GCP-3 procedure for conducting GCP inspections requested by the EMEA (English only) adopted 2007-09-20    
Annex I to procedure for conducting GCP inspections requested by the EMEA: Investigator site (English only) adopted 2007-09-20    
Annex II to procedure for conducting GCP inspections requested by the EMEA: Clinical laboratories (English only) adopted 2007-09-20    
Annex III to procedure for conducting good-clinical-practice inspections requested by the European Medicines Agency: Computer systems (English only) adopted 2007-11-28 2012-09-06  
Annex IV to procedure for conducting GCP inspections requested by the EMEA: Sponsor site and/or Contract Research Organisations (CRO) (English only) adopted 2007-09-20    
Annex V to procedure for conducting GCP inspections requested by the EMEA: Phase I units (English only) adopted 2008-07-23    
Annex VI to procedure for conducting GCP inspections requested by the EMEA: File structure and archiving of documents relating to CHMP requested inspections - in member state and at EMEA (English only) adopted 2007-09-20    
Annex VII to procedure for conducting GCP inspections requested by the EMEA: Bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials (English only) adopted 2008-05-28    
INS-GCP-4 procedure for reporting of good-clinical-practice inspections requested by the CHMP (English only) adopted 2007-09-20 2013-07-30  
Appendix 1 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report at sponsor site (English only)   2013-07-29    
Appendix 2 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report at investigator site (English only)   2013-07-29    
Appendix 3 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP inspection report at bioequivalence / bioavailability site (English only)   2013-07-29    
Appendix 4 to INS-GCP-4 procedure for reporting of GCP inspections requested by the CHMP: GCP integrated inspection report (English only)   2013-07-29    
Principal documents taken into account for the preparation of procedures for GCP inspections requested by the EMEA (English only)   2007-09-20