"The U.S. Food and Drug Administration has determined the agency will recognize 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," the FDA stated on its website.
The Croatian agency HALMED is among the eight European drug regulatory authorities.
"This achievement marks an important milestone to successful implementation and operationalization of the amended Pharmaceutical Annex to the 1998 U.S.-European Union (EU) Mutual Recognition Agreement (MRA) that enables U.S. and EU regulators to utilize each other's good manufacturing practice inspections of pharmaceutical manufacturing facilities," the FDA stated.
The head of HALMED, Sinisa Tomic, said on Friday that this was confirmation of the high-quality and professional work of the agency and its staff.
The FDA has completed eight capability assessments as part of the Mutual Recognition Agreement between the U.S. and the European Union and the decision took effect on 1 November.