EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA) are phasing 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. 

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. 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 extraordinary flexibilities ensured the continued availability of medicines while making sure that good manufacturing (GMP) and distribution practice (GDP) standards were being adhered to. 

From now on, the regulatory flexibilities that were introduced jointly by the HMA, EC and EMA specifically during the COVID-19 pandemic should no longer be granted. For already approved labelling flexibilities, e.g. the English-only labelling for COVID-19 vaccines, their application will be extended until the end of 2023, in order to ensure a smooth phase-out and avoid any supply difficulties or other disruptions due to a sudden change in applicable requirements. After 2023, the regular mechanisms foreseen in the legislation in relation to labelling exemptions should be followed.

Concerning on-site GMP and GDP inspections, these 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.

Experiences gathered during the application of the COVID-19 regulatory flexibilities are being collected by EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG). They will consider how lessons learned can inform best practices for tackling medicine shortages in case of new and emerging health challenges in the future.

Notes

  • The guidance has been continuously updated since its first publication in April 2020. In July 2022, EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) supported keeping these exceptional measures in place at that time. Some similar regulatory flexibilities were also in place for companies responsible for veterinary medicines. 

How useful do you find this page?

Average: