Snapshot

The FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products pathway has been developed by the of EU-EMA.

This pathway can be used where complex generic drug products/hybrid products..

This pathway facilitates activities during development.

It is an abridged review (a reliance pathway).

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. There are three stages in the pilot PSA meeting process: 1) Stage 1, applicants request a meeting with EMA and FDA (14 days); 2) Stage 2, EMA and FDA assess the meeting package, the agencies conduct a preparatory bilateral meeting, and then conduct a trilateral meeting with the applicant (120 days); and 3) Stage 3, EMA and FDA communicate written responses to the applicant (30 days). Requests for PSA meetings will be granted based on the workload, availability of staff, and anticipated value to the PSA program. 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. Industry can 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. The trilateral meeting will generally be one and a half hours but may be longer based on the number and complexity of questions to be discussed in the meeting. After the PSA process, each agency will retain its individual regulatory decision-making regarding drug development and marketing applications. The advice of each agency may still differ after the joint discussion. Each agency will provide the applicant with independent advice on the questions posed during the PSA meeting, according to usual procedures and timelines. Participation in the PSA program will not be construed to ensure any particular action on a marketing application by either agency. However, both agencies will strive to provide PSA responses that are convergent or explain differences.