European GMP and GDP certificates validity extended till end of 2024 Read More

The GMP/GDP Inspectors Working Group coordinated by EMA has decided to continue the extension of the validity of the GMP and GDP certificates until 2024 or the conclusion of the next on-site inspection, whichever comes first. EMA, the European Commission and Heads of Medicines Agencies (HMA) have phased out the extraordinary regulatory flexibilities put in place during the COVID-19 pandemic. On-site GMP and GDP inspections have restarted. However, a considerable number of postponed inspections still need to be carried out. 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. Meanwhile manufacturers should note that 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

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