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AAM And Medicines For Europe Urge Transatlantic Framework For Complex Generics

Regulatory Convergence Across The Atlantic Could Help Improve Complex Generic Development

 
• By Urtė Fultinavičiūtė

A proposed joint framework for complex generic development between the US and EU could reduce study duplications by eliminating the need to use locally approved comparators, a move that has been embraced by other regions and international organizations.

US and EU flags on cogs in machine
A joint development program is a shared objective of the EU and US health authorities • Source: Shutterstock

European and US generics and biosimilars organizations Medicines for Europe and the Association for Accessible Medicines have released a joint statement urging a common EU and US development program for complex generics, as the transatlantic political body EU-US Trade and Technology Council gathered to discuss key trade and economic issues in Washington DC on 30 January.

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