Hero image
Image
Inspections
Pre heading
CHAPTER 2 - DATA HIGHLIGHTS

Inspections and compliance

Assembly area
Heading

Rich text

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 2020. For more detailed information, download the full annual report 2020 (PDF version).

Heading

Rich text

GMP - GOOD MANUFACTURING PRACTICE

First column content
Image
170 GMP inspections requested by EEA authorities in 2020
Second column content
Image
1843 certifications and 1 non-compliance statement issued by EEA authorities
Heading

Rich text

GCP - GOOD CLINICAL PRACTICE

First column content
Image
59 GCP inspections requested in 2020
Second column content
Image
715 GCP inspections finalised by EEA authorities in 2020
Heading

Rich text

PHARMACOVIGILANCE INSPECTIONS & MARKET SURVEILLANCE

First column content
Image
16 Pharmacovigilance inspections requested by the CHMP or the CVMP
Second column content
Image
170 suspected quality defect notifications received by EMA, of which 157 were confirmed quality defects that led to batch recalls of 17 centrally authorised medicines