FDA, EMA Initiate Complex Generics Parallel Scientific Advice Pilot

The FDA and the European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice to applicants seeking marketing authorization from the EMA for hybrid products and for those filing abbreviated new drug applications (ANDAs) with the FDA for complex generic drugs.

The pilot will provide a mechanism for the agencies to concurrently consider and jointly exchange their views on scientific questions with applicants during the development phase of the generic products.

Candidates for the program include product development programs that may benefit from harmonized approaches. For example, EMA said, an applicant can use the program to figure out whether a study design is acceptable to both regulatory agencies.