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FDA-EMA Pilot Could Further Push Global Generic Harmonization, But Will Sponsors Use It?

Industry Offers Varied Responses On US-EU Pilot Program For Complex Generics And Hybrids

 
• By Derrick Gingery

Regulators hope parallel scientific advice pilot for complex generics is more popular than brand program was at start; sponsors want use of foreign comparator products and tighter harmonization.

The FDA-EMA parallel scientific advice pilot for complex generics is an expansion of the existing program for new drugs and biologics • Source: Alamy

Joint development advice from the US Food and Drug Administration and European Medicines Agency on generic drugs has the potential to push both regulators to align their standards, and the potential for faster and cheaper drug approvals globally excites industry.

The grand dream, which could save sponsors millions by preventing duplicative clinical studies and unnecessary testing, likely is a long way off, given the legal and other changes that may be necessary

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