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FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products

FDA and European Medicines Agency (EMA) have launched a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applications (ANDAs) for FDA’s complex generic drug products and of marketing authorization applications (MAAs) for EMA’s hybrid products. This pilot program is an expansion of FDA and EMA’s existing PSA for new drugs and biological products.

The pilot program allows prospective applicants of ANDAs to FDA and MAAs to EMA to submit a request for a meeting with both agencies to discuss specific questions regarding the development of complex generic drug/hybrid products. The goal of the PSA pilot program is 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. Through the PSA process, applicants would gain an understanding of both agencies’ recommendations.

Successful collaboration between FDA and EMA via the PSA pilot program may provide applicants with a deeper understanding of the basis of regulatory decisions from both agencies, optimize applicants’ global product development programs, and help applicants avoid unnecessary replication of studies or unnecessary diverse testing methodologies to satisfy both agencies, which can shorten the time to approval.

Industry can now request PSA meetings for complex generic drug/hybrid products by sending a single “Request for PSA” letter (justification letter) to both EMA at emainternational@ema.europa.eu and FDA at preANDAHelp@fda.hhs.gov to initiate the PSA process.

Meeting requests will be received until FDA and EMA determine the number of completed PSA meetings is sufficient to assess the pilot program. During and after conclusion of the pilot, each agency will evaluate the benefits and challenges of the program, including the resources required, and determine next steps. Refer to the General Principles document for FDA and EMA’s recommendations on what to include in this request and the subsequent PSA processes.

Questions about the program may be directed to preANDAHelp@fda.hhs.gov.

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