New priorities set for trans-Atlantic collaboration on medicines

As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration.
 
“In the context of the COVID-19 pandemic, the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA),” said EMA in announcing the outcome of the 2-day meeting, held 18 and 19 June. “Given the medical emergency presented by COVID-19 and the importance of international cooperation to tackle this global crisis, the topic was high on the agenda of the bilateral meeting.”
 
The meeting represents a continuation of the collaboration between EMA and FDA that began formally in 2003. Now, said EMA, the two agencies work together on a near-daily basis “with the aim to better align, and advance scientific and regulatory excellence worldwide.”
 
At the meeting, the regulators went over challenges each are facing in the race to develop vaccines for COVID-19 and make them available. The regulators, through ICMRA, are collaborating on other aspects of COVID-19 research, including using observational research to build out real-world evidence on vaccine surveillance, increasing collaboration and reducing hurdles to conduct research with international cohorts, and investigating the use of medicines for COVID-19 in pregnant women.
 
Here, the discussion centered around “methods for generating evidence and opportunities to strengthen collaboration leveraging data from diverse digital sources to inform regulatory decisions,” said EMA, noting that an international roadmap for collaboration on real-world evidence collection is in the works.
 
Other topics of discussion included bespoke therapies, such as gene therapies and oligonucleotides, for ultrarare diseases. Orphan and pediatric medicine initiatives by both FDA and in Europe were discussed, with an eye to achieve cooperative data analysis to characterize rare diseases.
 
Finally, a mutual recognition agreement of good manufacturing practice inspections that is already fully implemented for certain human medicines will be expanded, with plans to include veterinary medicines and the potential to include vaccines and plasma-derived products by July 2022.