The CMDh, in line with EMA, the European Commission (EC) and the Heads of Medicines Agencies (HMA), is 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 (see also EMA/EC/HMA announcement). 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. Also, 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 was agreed during the pandemic. 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 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.
EMA and the European medicines regulatory network are lifting their respective COVID-19 business continuity measures after successfully handling the unprecedented operational challenges posed by the pandemic.
The business continuity plan for the European medicines regulatory network set out the principles to ensure that EMA, the European Union (EU) Member States and the European Commission could continue to operate their core regulatory activities while prioritising the assessment of COVID-19 treatments and vaccines to protect public and animal health in the EU during the pandemic.
While the temporary measures that were introduced to cope with the peak impact of the COVID-19 pandemic are no longer required, resourcing within the entire European medicines regulatory network remains a challenge. The CMDh will continue to work closely with EMA and the Heads of Medicines Agencies from the Member States to identify and implement sustainable solutions. Experiences gathered during application of the EMA and network business continuity plans, as well as lessons learnt during the pandemic, will inform this work.
The lifting of the COVID-19 business continuity measures is timely in view of World Health Organization (WHO)'s recent announcement on the end of the Public Health Emergency of International Concern (PHEIC) status of COVID-19.