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# New FDA/EMA Complex Generic/Hybrid Advice Pilot
- URL: https://www.fdaweb.com/new-fda-ema-complex-generic-hybrid-advice-pilot/
- Published: 2021-09-15T12:00:00.000Z
- Updated: 2026-09-14T17:14:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150146

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](https://www.fda.gov/drugs/generic-drugs/global-generic-drug-affairs?utm%5Fmedium=email&utm%5Fsource=govdelivery) 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.