FDA-EMA Parallel Scientific Advice Program For Complex Generics Could Add Health Canada

The FDA-EMA parallel scientific advice (PSA) program for complex generics soon could add another regulator, which may increase the appeal of the meeting process intended to streamline patient access to the products.

Health Canada is interested in joining the group, which would make the trilateral PSA meetings (US Food and Drug Administration, European Medicines Agency, and sponsor), potentially quadrilateral.