USFDA and EMA Parallel Scientific Advice for Complex Generics

Prospective applicants of Complex Generics (CG) can request for a joint meeting with FDA OGD (Office of Generics Drugs) and EMA (European Medicines Agency) for scientific advice on development of the generics. Engaging with regulatory agencies at an early stage can improve the scientific quality and validity of a generic drug applicant’s development strategy and minimize future regulatory obstacles. This is especially important given the significant investments in research and development for the complex generics. Joint meeting helps the applicant receive feedback from both regulatory bodies simultaneously, avoid redundancy in testing and helps drug approval in both areas of the globe. Parallel scientific advice can be on subjects like single BE study that may satisfy both agencies, use of a common comparator in BE studies (RLD or RLD equivalent), use of modelling and simulation in development program.

In a Blog post, Sarah Ibrahim, PhD, the Associate Director of Stakeholder and Global Engagement at the Office of Generic Drugs in CDER, discusses the voluntary pilot programme launched to facilitate concurrent discussion between generic drug applicants and the two regulatory bodies. Sarah Ibrahim addresses any apprehension/hesitation of applicants on joint scientific advice that conflicting advice from both agencies could require additional testing and reassures that past experiences have shown that this is not the case and such apprehensions are unnecessary.

Currently this is a pilot program and FDA and EMA will “ continue to receive meeting requests until the agencies determine the number of completed PSA meetings is sufficient to assess the pilot program” and encourage applicants to participate in the pilot program. A joint PSA meeting can be requested by applicants by sending a single “Request for PSA” justification letter to both EMA at emainternational@ema.europa.eu and FDA at preANDAHelp@fda.hhs.gov.

CDER’s OGD and EMA’s Parallel Scientific Advice Pilot Program for Complex Generics Works to Increase Harmonization and Bring Generic Drugs to Patients (FDA Blog)