More Non-Compliance Statements issued by EMA

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The number of GMP inspections requested by the CHMP or CVMP and co-ordinated by the European Medicines Agency (EMA) in accordance with EU legislation has increased from 567 in the year 2015 to 672 in 2016 (420 in 2014).

According to the 2016 Annual Report of the European Medicines Agency EMA, which was recently published, the number of these inspections increased by 18.5% in 2016, linked to the "growing number of centrally authorised products".

But these inspections requested by the CHMP represent only a part of the total number of inspections performed by the EU/EEA inspectors (from national competent authorities), because they also "carry out inspections as part of their national programmes". All these inspections should be listed and summarised in the EudraGMDP database operated by EMA.

So overall 2.293 GMP inspections were performed last year (within the Member States but also globally). From these inspections, approximately 1% led to the issue of a non-compliance statement (24 in total). One percent seems to be a rather low rate but every GMP Non-Compliance Statement is one Statement too much. And the total number is growing. In 2015, 18 GMP Non-Compliance Statements were issued and 16 in 2014. And there seems to be a growing problem with companies in India, as the number of GMP Non-Compliance Statements has doubled (from 6 to 12). But also three companies in the USA have received such a statement (only one in the last three years).

These GMP Non-Compliance Statements can lead to a

• supply stop
• removal of a manufacturing site from the dossier
• removal/ replacement of a manufacturing site during the assessment procedure (prior approval)
• withdraw of an application for marketing authorisation
• recall of medicinal products