Europe Acts On Counterfeit Drugs

The European Parliament has approved a directive guarding against the shipment of counterfeit active pharmaceutical ingredients (APIs) into the European Union. Under the Directive on Falsified Medicines, shipments of APIs must include a statement from health authorities in the country of origin that the product was manufactured according to current Good Manufacturing Practice (cGMP) standards or the equivalent. The directive requires that API manufacturers in the EU register with national health authorities and outlines an auditing regimen for suppliers outside the EU. It also establishes a public database on cGMP certification. “We have much to celebrate,” says Guy Villax, CEO of Lisbon-based Hovione and an advocate for international monitoring of API shipments on behalf of the European Fine Chemicals Group.