Processing Magazine

US, EU generic drug makers call for regulatory cooperation

April 16, 2014
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Generic pharmaceuticals manufacturers from Europe and the United States have urged regulators on both sides of the Atlantic to adopt a strategy of "regulatory convergence." The U.S. Generic Pharmaceutical Association (GPhA) and European Generic medicines Association (EGA) have sent a letter to the European Commission and the Office of the U.S. Trade Representative, claiming that a common strategy would result in new jobs being created and higher revenues for the industry, while at the same time it would facilitate consumers' access to much needed medicines.

The two trade associations believe that Transatlantic Trade and Investment Partnership (TTIP) negotiators should aim to make regulatory processes more streamlined by focusing on eliminating duplications and redundancies. The letter, signed by Ralph Neas, president and chief executive of the GPhA, and Adrian van den Hoven, director general of the EGA, called for improved cooperation between the U.S. Food and Drug Administration and the European Medicines Agency so that biosimilar development pathways could be converged. The generic drugs manufacturers also asked regulators to develop a single approval pathway for generics because manufacturers are currently expected to follow two different processes to have their products approved.

The letter further stated that regulators should recognize each other's good manufacturing practice inspections, so that better compliance is ensured, allowing the agencies to allocate more resources to inspections outside the United States and the European Union. And the GPhA and EGA recommended that plans for increasing patent protection should be scrapped, claiming that it is unnecessary and would have a negative economic impact in both regions.