Testing transparency: Making FDA work more effective

Amidst growing drug development and manufacturing costs, setting up globalized drug making sites has become more common among pharma companies in the last decade or so, comments Dr Nicola Davies in her monthly exclusive for The Pharma Letter. According to the Food and Drug Administration, the amount of drug imports they regulate has doubled since 2004.

To ensure the safety and effectivity of drug or drug components imported into the USA, the FDA runs the Globalization Initiative. This initiative requires synergy with foreign regulatory counterparts and the assigning of staff in some foreign locations including Europe, Latin America, India and China. FDA activities include routine inspections of overseas manufacturing plants for compliance with regulations and Good Manufacturing Pratices (GMP) and the random sampling of drugs stored in retail stores, warehouses of distributors, and manufacturing facilities. This initiative is supposed to guide FDA activity in terms of enforcement, surveillance, and regulation design.

Drug making in China