New FDA/EMA Complex Generic/Hybrid Advice Pilot

FDA and the European Medicines Agency (EMA) are starting a pilot program to provide parallel scientific advice to applicants of ANDAs for FDA’s complex generic drug products and marketing authorization applications (MAAs) for EMA’s hybrid products. An FDA statement says the pilot expands the two agencies’ existing parallel scientific advice program for new drugs and biological products.

Under the pilot, prospective ANDA and MAA applicants can submit a request for a meeting with both agencies to discuss specific questions about developing complex generic drug/hybrid products. The program goal is said to be to provide a mechanism for FDA and EMA assessors to concurrently exchange their views on scientific issues with applicants during the development phase of complex generic drug/hybrid products, which are generally more challenging to develop with traditional bioequivalence methods.