EU and US Discuss Regulatory Collaboration
Members of the European Commission, EMA, and FDA met in a virtual two-day meeting to discuss ongoing joint initiatives and upcoming priorities.
Members of the European Commission, the European Medicines Agency, and the US FDA held their 2020 bilateral regulatory meeting virtually from June 18–19, 2020. The agencies discussed ongoing joint initiatives and strategies for collaborating in the future.
The agencies, which have been collaborating since 2003 with daily interactions and working groups, have been working more closely amid the COVID-19 pandemic, specifically through the International Coalition of Medicines Regulatory Authorities. Among the topics discussed at the meeting, therefore, was the development of a COVID-19 vaccine. The agencies also discussed the use of real-world evidence to support regulatory decisions and agreed to use observational research in COVID-19 as a model. The focus of these discussions was on data provenance, quality, and structure, as well as methods for generating evidence and leveraging data from diverse digital sources.
In addition, therapies for ultrarare diseases, orphan and pediatric medicines, and expansion of the mutual recognition agreement were discussed.
Source: EMA
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
New Cancer Research and Treatment Center in Development in London
May 1st 2025Aviva Capital Partners and developer Socius are investing £1 billion in a 12-acre site to be located at the London Cancer Hub next to The Institute of Cancer Research, London and The Royal Marsden NHS Foundation Trust’s Sutton site.
Regeneron Treatment for Multiple Myeloma Gets Conditional Marketing Approval from EC
April 29th 2025The indication is specific to patients who have received at least three prior therapies, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
