The European Medicines Regulatory Network (EMRN) has been at the forefront of the fight against COVID-19 with its crucial role in the evaluation and monitoring of medicines, including vaccines. A joint report issued by the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) reviews the Network’s response and highlights the main learnings for any future health crises.
This review highlights some of the unprecedented challenges related to COVID-19 that had to be addressed, the activities and areas that enabled the effective response to the COVID-19 emergency and provides recommendations on which improvements are needed.
Accelerated procedures for the evaluation of COVID-19 vaccines and therapeutics, as well as scientific recommendations on the use of certain medicines enabled the public health response through safe and effective prevention and treatment options.
The Network pooled its resources to address the increased workload and new tasks like managing medicine shortages, generating evidence on COVID-19 medicines in the real-world setting and regularly providing reliable and science-based information to the public.
Additionally, the European Union (EU) safety monitoring and risk management system was strengthened to collect and monitor the high volume of data from the mass vaccination campaigns. This allowed the Network to promptly identify, assess and manage safety issues.
Collaboration between EU and international partners was also crucial to ensure that regulators around the world adopted a coordinated approach to COVID-19 treatments and vaccines.
Throughout the COVID-19 crisis, the EMRN also ensured that medicines for other diseases affecting Europeans continued to be evaluated and supervised without delays.
The report suggests that more can be done in terms of the ability to set up large clinical studies in a rapid manner. In terms of real-world data, there is a need to gather multiple data sources that can generate useful evidence for regulatory assessments.
The report also acknowledges the need to have a larger pool of experts that can be involved to carry out scientific assessments (such as accelerated reviews for promising medicines) when crisis situations arise.
The report has been adopted by EMA’s Management Board. Several recommendations have already been implemented as part of EMA’s extended mandate, with the Agency assuming an enhanced role on preparedness to be more proactive on public health threats. HMA and EMA also continue working closely on areas such as resourcing, process improvements and communication. In addition, the ongoing review of the EU pharmaceutical legislation will also provide a vehicle to bring about other changes to the EU regulatory toolbox. The recommendations will also be considered in future updates of the European Medicines Agencies Network strategy.
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