EMA Good Clinical Practice (GCP)Ensuring international ethical and scientific quality standards for designing, recording and reporting trials that involve people

1,000 GCP inspectionsOn 7 October 2019, the 1,000th good clinical practice (GCP) inspection requested by EMA’s human medicines committee (CHMP) and coordinated by EMA was performed at a clinical investigator site in Toronto (Canada) by inspectors from Austria and Poland.

What is GCP?GCP is an international ethical and scientific quality standard for designing, recording and reporting trials that involve people. GCP inspections are an essential tool for verifying compliance and providing public assurance that the rights, safety and wellbeing of the individuals who participate in trials are protected, and that clinical-trial data are credible.

Routine inspections:Carried out as a routine surveillance of GCP compliance, in the absence of specific issues.

Non-routine inspections:Triggered by issues arising during the assessment of the dossier.

1997 1999 2001 2003 2005 2007 2009 2011 2013 2015 2017 2019

GCP inspections requested by the CHMP (per year and type)

Non-Routine Routine

Australia/New Zealand

242Africa

254

Middle East/Asia/Pacific

12730

EU/EEA/EFTA

215174

Central/SouthAmerica

5312

USA

16284

Canada

2510

Eastern Europe (non EU)

91

Commonwealth of Independent States (CIS)

2914

Non-Routine RoutineGCP inspections requested by the CHMP (per region and type)

20

40

60

80

100

GCP inspections have taken place in 70 countries

The GCP inspection

programme started in 1997

with an inspection in Amsterdam

1,000th

inspection took place on

7 October 2019 in Toronto,

Canada