Progress in Regulatory Harmonization? Europe adopts GMP regulations for APIs

Last October, Europe formally set standards for active pharmaceutical ingredients (API), so that all APIs sold in Europe and used in drug formulations must be manufactured at facilities that meet GMP requirements. Presently a huge number of API manufacturers supply the European pharmaceutical manufacturing market, and product quality varies widely. Although standards will help level the playing field, observers believe that the new requirements do not go far enough, and that GMP licensing should be required. What is clear, though, is that the onus will now be on It drug manufacturers to vet suppliers and ensure that their APIs are coming from a reputable source. A recent article from Chemical and Engineering News discusses developments. - AMS