EMA, the European Commission and Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities for medicines put in place during the COVID-19 pandemic to help address regulatory and supply challenges arising from the pandemic.

This follows the end of the COVID-19 public health emergency declared by WHO in May 2023.

On-site GMP and GDP inspections have restarted after being postponed or carried out remotely during the pandemic.

However, a considerable number of postponed inspections still need to be carried out.

The validity of GMP and GDP certificates was extended until the end of 2023. The GMP/GDP Inspectors Working Group has decided to continue the extension of the validity date until 2024 or the conclusion of the next on-site inspection, whichever comes first, except where clarifying remarks in the document state otherwise. 

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.

The inspections will be prioritised based on risk, so that the highest priority manufacturers, such as manufacturers of sterile product and biological products, and wholesale distributors are inspected first. In addition, inspections will be prioritised depending on the date of the last inspection.

Questions about the validity date of a GMP or GDP certificate should be addressed to the competent authority that issued the certificate. 

It is incumbent upon manufacturers, importers and distributors to continue complying with GMP and GDP as appropriate. 

Supervisory authorities will remain vigilant to ensure the quality of medicines that are made available to patients in the EEA.

Inspections (including distant assessments) may be carried out at any time. In case of serious non-compliance, appropriate regulatory actions will be triggered.

The guidance was agreed by the GMP/GDP Inspectors Working Group coordinated by EMA. It will be updated when there is additional information available.