The European Medicines Agency (EMA) and the European Medicines regulatory network have announced the lifting of COVID-19 business continuity measures, signifying a step towards normalizing regulatory processes as pandemic trends shift. These measures were introduced in 2020 to prioritize the assessment of COVID-19 therapeutics and vaccines, and as a part of this, COVID-19 medicines were given priority in various pharmacovigilance procedures.
Now, the EMA plans to systematically reinstate the activities and processes that were previously suspended or scaled back due to the pandemic. This gradual restoration of operations is a positive indication of progress towards resuming normal regulatory functions. Additionally, the EMA has set its sights on restarting the publication of clinical data for new active substances in the coming months.
The European medicines regulatory network has in it regulatory agencies from the member states of the European Economic Area. These member states encompass all the countries of the European Union, along with Iceland, Liechtenstein, and Norway, which are not EU members. This network brings together the regulatory authorities of these countries to collaborate and harmonize their efforts in overseeing the safety and efficacy of medicines within the EEA region.
In the global response to the COVID-19 pandemic, the recent announcement aligns with actions taken by the World Health Organization (WHO) and US authorities. President Joe Biden signed a resolution ending the COVID-19 national emergency, and the US Public Health Emergency ended on May 11. WHO’s Director-General, Tedros Adhanom Ghebreyesus, emphasized that while COVID-19 remains a health concern, it no longer holds the status of a public health emergency of international concern.
EMA’s Executive Director, Emer Cooke, sees this announcement as a major milestone and emphasizes that the agency will adapt its approach accordingly. Leveraging the lessons gained from the COVID-19 pandemic, the EMA aims to influence its strategy in various domains. In particular, it will concentrate on anti-cancer medicines this year to effectively apply the knowledge obtained. The European Medicines Agency’s programming document for 2025 highlights six critical areas of emphasis, demonstrating their commitment to ensuring the availability of medicines and addressing the risks posed by antimicrobial resistance and other emergencies.