EU and MHRA extend GMP and GDP Certificates

Recommendation

15-17 May 2024
Berlin, Germany

The GMP-Auditor
Initial and Continuous Professional Training for GMP Auditors

EMA, the European Commission and the Heads of Medicines Agencies (HMA) had allowed the extraordinary flexibility arrangements for medicines introduced during the COVID-19 pandemic to expire in order to address the regulatory and supply challenges created by the pandemic (see end of the COVID-19 emergency declared by the WHO).

On-site GMP and GDP inspections resumed after being postponed or conducted remotely during the pandemic. However, a significant number of postponed inspections still need to be carried out.

The validity of the GMP and GDP certificates has already been extended until the end of 2023. The GMP/GDP inspectors' working group has now decided to continue the extension of the validity date until 2024 or until the completion of the next on-site inspection, whichever comes first, unless otherwise stated in the document.

In the meantime, competent authorities will conduct risk-based surveillance of sites, either through on-site inspections or distant assessments, and depending on the outcome, they may continue to issue, withdraw or restrict GMP and GDP certificates, as appropriate.

Inspections are prioritised according to risk, so that the highest priority manufacturers, e.g. sterile and biological product manufacturers, and wholesalers are inspected first. In addition, inspections are prioritised according to the date of the last inspection. Inspections (including remote assessments) can be carried out at any time. Appropriate regulatory action will be taken in the event of serious violations.

Questions regarding the validity date of a GMP or GDP certificate should be directed to the competent authority that issued the certificate. It is the responsibility of manufacturers, importers and distributors to continue to comply with GMP and GDP regulations.

Guidance will be updated as additional information becomes available.

Also MHRA has decided to continue the extension of the validity date until 2024.