13/14 December 2023
The European Medicines Agency (EMA), the European Commission (EC), and the Heads of Medicines Agencies (HMA) are phasing out the extraordinary regulatory flexibilities for medicines that were 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 the WHO in May 2023.
The extraordinary regulatory flexibilities covered different areas, including marketing authorization and related regulatory procedures, manufacturing and importation of active pharmaceutical ingredients and finished products, quality variations, labelling and packaging requirements, and compliance. The EC, HMA, and EMA also agreed during the pandemic on a series of measures to mitigate the impact of disruptions caused by the public health emergency on inspections of manufacturing facilities or other sites relevant for medicinal products in the EU.
The defined flexibilities ensured the continued availability of medicines while making sure that Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) standards were being adhered to. From now on, the regulatory flexibilities should no longer be granted.
For manufacturing in particular, this means that 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. This Group has also reviewed experiences with remote working arrangements of Qualified Persons during the pandemic, and will issue guidance on how those specific arrangements can be applied in the future.
Source: EMA News