Complex Generic/Hybrid Drugs Pilot Expands

FDA and the European Medicines Agency (EMA) are expanding their Parallel Scientific Advice (PSA) pilot program to include a voluntary pilot on complex generic or hybrid drugs. (Hybrid drugs is an EMA term that loosely corresponds to FDA’s complex generics terminology.)

Writing in an online post, CDER Office of Generic Drugs associate director of stakeholder and global engagement Sarah Ibrahim says that advancing complex generic drug development is a critical part of FDA’s goal to help patients access safe, effective, and high-quality generic medicines.

The pilot focuses on sharing information and regulatory perspectives, Ibrahim writes, and allows prospective generic drug applicants to engage in concurrent scientific conversations on key issues with both agencies during the drug development phase.

“Under the pilot program,” she says, “applicants can request a joint meeting with FDA and EMA to address specific scientific inquiries pertaining to the development of complex generics or hybrid medicines.” Such meetings help applicants receive feedback from both regulatory bodies simultaneously and work toward drug approval in both areas of the globe, the post says.

So far, Ibrahim says, two applicants have been granted PSA meetings and completed the PSA process. They have recommended that the agencies provide procedural clarifications, clarify program timelines and expectations, and share best practices for meeting package preparation and participation. She says FDA and EMA intend to implement the key recommendations to improve the PSA process.

The agencies will continue to entertain meeting requests until they determine there have been enough participants to be able to evaluate the program.