FDA And EMA Collaborate On Advice For Complex Generics And Hybrids

US-EU Pilot Program Will Provide Parallel Scientific Advice For Applicants

16 Sep 2021

The US FDA and EMA have announced a pilot program to provide parallel scientific advice on complex generics and hybrid medicines for prospective applicants, with a goal of harmonization and increased regulatory convergence.

The US and EU agencies are working together on complex generics and hybrids • Source: Alamy

A pilot program that will see the US Food and Drug Administration and European Medicines Agency provide parallel scientific advice on complex generics and hybrid medicines to prospective applicants has been announced by the two regulators.

“This pilot program is an expansion of FDA and EMA’s existing PSA for new drugs and biological products,” the FDA...