Global health regulators collaborate: International Coalition of Medicines Regulatory Authorities

Founded in 2019, the International Coalition of Medicines Regulatory Authorities (ICMRA) collaborates to review changes to manufacturing or add manufacturing sites to “enable better industry quality management to reliably supply critical medicines for patients in need”.  An article posted by the FDA announces recent progress and future plans (here).

ICMRA has just completed a pilot.  The article notes that the “FDA and EMA regulators completed the first collaborative assessment of a proposed post-approval change for a critical oncology biologic with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) serving as an observer. The work, in which FDA and EMA reviewed and approved a proposal to add new manufacturing and quality control sites, can help assure the supply of the medicine.”

 

Other activities and future plans make an interesting read, and if successful will simplify and speed future approvals of new therapies and subsequent modifications of their manufacturing to ensure global therapy supply.