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FDA-EMA Pilot Advice Scheme On Complex Generics Sees Slow Uptake

Two Applicants Have Completed The US-EU Parallel Advice Process So Far

 
• By Urtė Fultinavičiūtė

While approaching the third year of its launch, the parallel advice program has seen a handful of applicants, but regulators on both sides of the Atlantic remain optimistic.

Tiny people standing on jigsaw puzzle pieces with EU and US flags
The voluntary pilot was launched in 2021 • Source: Shutterstock

A collaborative scheme between the US Food and Drug Administration and the European Medicines Agency is yet to be embraced by complex generic developers. According to the FDA’s latest update on the parallel scientific advice scheme, only two applicants were granted PSA meetings and have completed the process more than two years after its launch.

Based on the preliminary applicant feedback to the program, agencies were recommended to “provide procedural clarifications, clarify program timelines and expectations, and share best practices for meeting package preparation and...

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