Drug Standards Sought

The European Fine Chemicals Group, a trade association, is calling for a global harmonization of regulations governing the manufacture of active pharmaceutical ingredients (APIs). The group hopes to “level the worldwide playing field” by ensuring that all pharmaceutical chemicals meet standards set by U.S. and European Union regulatory authorities. EFCG proposes a “mutual recognition agreement” under which regional regulators share inspection resources to avoid duplicating efforts in inspecting plants that manufacture APIs coming into Europe. The proposal was submitted late last month to the EU-U.S. High Level Regulatory Cooperation Forum, an initiative focused on regulatory liaison between the U.S. and Europe. EFCG argues that the EU’s recently enacted Falsified Medicines Directive, designed to minimize counterfeit medicines entering the EU, does not adequately address issues of general API quality. It points to illegal manufacturing of drug chemicals in Asia as the key threat.