Generic Makers Call for More EU-U.S. Collaboration on Approvals, Inspections

GPhA and its European counterpart want the FDA and European Medicines Agency to create uniform approval pathways for biosimilars and generics, saying standardization would lower drug costs and eliminate the need for duplicate clinical trials for the same product.

U.S. and European trade representatives are negotiating a trade agreement called the Transatlantic Trade and Investment Partnership, and the generics industry hopes to use it to eliminate some regulatory inconsistencies between the U.S. and EU.

In a letter to negotiators, GPhA and the European Generic medicines Association also ask EU and U.S regulators to mutually recognize good manufacturing practice inspections, making multiple inspections by different U.S. and EU regulators unnecessary.

In addition, they want the U.S. and EU to allow generics and biosimilars makers to begin manufacturing products that are still under patent so that they can be distributed as soon as possible after patent expiration.

While GPhA and EGA advocate more collaboration on approvals and inspections, they oppose harmonizing patent systems, another issue the negotiations are touching on.

The European Commission has said that the intention of TTIP is not harmonization, but to address specific issues related to patent protection.

TTIP negotiations began in July 2013 and will continue this year.  While no timeline is set to finalize the deal, both sides want to “avoid years of talks,” the commission said.

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