FDA and EMA Launch Program to Advise Prospective MAAs and ANDAs Applicants

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

FDA, in partnership with the European Medicines Agency (EMA), announced a pilot program to provide parallel scientific advice (PSA) to applicants of abbreviated new drug applicants on Sept. 15, 2021, in an EMA press release. This advice is geared toward applicants applying for FDA’s complex generic drug products or marketing and EMA’s marketing authorization applications of hybrid products.

The pilot program is an expansion of the existing PSA for new drugs and biological products offered by FDA and EMA. The goal of the new program is to allow FDA/EMA assessors to concurrently express their views on scientific issues with applicants during the development phase for generic drugs and hybrid products, providing applicants with the ability to harmonize proposals in advance of their application.

To request a meeting with the agencies, applicants should send a “Request for PSA” letter to the EMA at emainternational@ema.europa.eu and FDA at preANDAHelp@fda.hhs.gov. These requests will be received until the agencies determine that a sufficient number of meetings needed to assess the program have been scheduled.

Further questions about the program can be directed to preANDAHelp@fda.hhs.gov.

Source: EMA