Posted by Michael Wonder on 31 Oct 2017
FDA takes unprecedented step toward more efficient global pharmaceutical manufacturing inspections
31 October 2017 - Agency completes eight capability assessments as part of the Mutual Recognition Agreement between the U.S. and European Union.
The U.S. FDA has determined the agency will recognise eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities that meet FDA requirements. The eight regulatory authorities found to be capable are those located in: Austria, Croatia, France, Italy, Malta, Spain, Sweden and the United Kingdom.
This achievement marks an important milestone to successful implementation and operationalisation of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement that enables U.S. and EU regulators to utilise each other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities.
