CHAPTER 2 - DATA HIGHLIGHTS

Inspections and compliance

EMA coordinates the verification of compliance with the principles of good manufacturing practice (GMP), good clinical practice (GCP), good laboratory practice (GLP), good pharmacovigilance practices (GVP) and certain aspects of the supervision of authorised medicines in the EU. Here are some key figures for inspections in 2022. For more detailed information, download the full annual report 2022 (PDF version).

GMP - GOOD MANUFACTURING PRACTICE

180 GMP inspections requested by EEA authorities in 2022

2131 certifications and 6 non-compliance statement issued by EEA authorities

GCP - GOOD CLINICAL PRACTICE

PHARMACOVIGILANCE INSPECTIONS & MARKET SURVEILLANCE

12 Pharmacovigilance inspections requested by the CHMP or the CVMP

206 suspected quality defect notifications received by EMA, of which 185 were confirmed quality defects that led to batch recalls of 10 centrally authorised medicines

For more information, please read the full PDF document.

Print	ISBN 978-92-9155-074-6	ISSN 1725-3225	doi:10.2809/175386	TC-AA-23-001-EN-C
PDF	ISBN 978-92-9155-073-9	ISSN 2467-2106	doi:10.2809/08948	TC-AA-23-001-EN-N
HTML	ISBN 978-92-9155-075-3	ISSN 2467-2106	doi:10.2809/57707	TC-AA-23-001-EN-Q