BILLEV PHARMA EAST

NEWS

14 December 2023

EU and MHRA extend GMP and GDP Certificates

EMA, the European Commission, and the Heads of Medicines Agencies (HMA) have phased out the special regulatory flexibility measures for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic. The end of the COVID-19 public health emergency was declared by WHO in May 2023.

 

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

 

The validity of GMP and GDP certificates has already been extended until the end of 2023.

The GMP/GDP Inspectors Working Group has now decided to further extend this validity until 2024 or until the completion of the next on-site inspection, whichever comes first, unless otherwise stated in the document. The MHRA has also decided to continue the extension of the validity date until 2024 or until the conclusion of the next inspection, whichever comes first.

 

Meanwhile, competent authorities will perform risk-based supervision of sites, either by on-site inspections or distant assessments, and based on the outcome may continue to issue, withdraw, or restrict GMP and GDP certificates, as appropriate.

Inspections are prioritised based on risk, so that the highest priority manufacturers, such as manufacturers of sterile and biological products, and wholesale distributors are inspected first.

 

Furthermore, inspection scheduling considers the date of the last inspection. MHRA inspections will be prioritised if the GMP or GDP certificate is already five years or older. Inspections and remote assessments can be conducted out at any time. In case of serious non-compliance, appropriate regulatory actions will be taken.

 

Inquiries about the validity date of a GMP or GDP certificate should be addressed to the competent authority that issued the certificate. Manufacturers, importers, and distributors are responsible for ongoing compliance with GMP and GDP regulations.