Medicines
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 2021. For more detailed information, download the full annual report 2021 (PDF version). 

GMP - GOOD MANUFACTURING PRACTICE

369 GMP inspections requested by EEA authorities in 2021
1982 certifications and 5 non-compliance statement issued by EEA authorities

GCP - GOOD CLINICAL PRACTICE

36 GCP inspections requested in 2021

PHARMACOVIGILANCE INSPECTIONS & MARKET SURVEILLANCE

15 Pharmacovigilance inspections requested by the CHMP or the CVMP
178 suspected quality defect notifications received by EMA, of which 164 were confirmed quality defects that led to batch recalls of 10 centrally authorised medicines

For more information, please read the full PDF document.