AAM And Medicines For Europe Urge Transatlantic Framework For Complex Generics

Regulatory Convergence Across The Atlantic Could Help Improve Complex Generic Development

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.

In the statement released ahead of the 5th TTC meeting, AAM and Medicines for Europe called for both regions...