Biochemical Engineering Special Interest Group
biological engineering professionals
02 March 2017

FDA and EU enter deal on mutual recognition of GMP inspections

Drug makers in the EU and U.S. may no longer be required to undergo separate GMP inspections by the FDA and the competent authorities in EU member states following an agreement by the EU and U.S. regulators to recognize each other’s inspections of pharmaceutical manufacturing sites within their own territories. In effect, the two regulators should only have to inspect those EU or U.S. pharmaceutical manufacturing sites that aren’t on their own soil under exceptional circumstances. Source: Genetic Engineering News 2/3/2017

My IChemE

IChemE is a registered charity in England & Wales (214379), and a charity registered in Scotland (SC 039661).