FDA, EMA launch pilot program to provide scientific advice on complex generic, hybrid products
The Food and Drug Administration, in partnership with the European Medicines Agency, has launched a pilot program to provide parallel scientific advice to applicants of abbreviated new drug applications for FDA’s complex generic drug products and of marketing authorization application 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 goal of the new pilot program is to allow FDA and EMA assessors to concurrently exchange their views with applicants on scientific issues during the development phase of complex generic drug/hybrid products.
[Read more: FDA marks competitive generic therapy approval milestone]
Successful collaboration between FDA and EMA via the PSA pilot program is expected to provide applicants with a deeper understanding of the basis of regulatory decisions from both agencies, optimize applicants’ global product development program, and help applicants avoid unnecessary replication of studies or unnecessary testing methodologies to satisfy both agencies, which can prolong the development of complex generic products.
Applicants can now submit a request for a meeting with both agencies to discuss specific questions regarding the development of a complex generic drug/hybrid product. Applicants should send a single “Request for PSA” letter (justification letter) to both EMA and FDA here to initiate the PSA process.
[Read more: FDA touts Generic Drug Program's efforts to ensure supply amid COVID-19]
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 the 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 can be directed here.