EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the COVID-19 regulatory flexibilities. GMP and GDP inspections have been restarted. Validity of GMP and GDP certificates are currently extended until the end of 2023, and update on approach for 2024 will be issued in coming months Read More..

EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary COVID-19 regulatory flexibilities put in place during the COVID-19 pandemic. The extraordinary regulatory flexibilities covered different areas, including marketing authorisation and related regulatory procedures, manufacturing and importation of active pharmaceutical ingredients and finished products, quality variations, labelling and packaging requirements and compliance. On-site GMP and GDP inspections, have been 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 has currently been extended until the end of 2023, and the GMDP Inspectors Working Group will issue in the coming months an update on the approach for 2024, as per the EMA news update