Austria is among first participating member states in new mutual GMP inspection agreement between EU and US
As of November 1, 2017, parts of the Mutual Recognition Agreement (MRA) between the EU and the US entered into force. This agreement updates the original, unratified 1998 agreement and enables mutual recognition of inspection results (Good Manufacturing Practice, GMP) and thus better use of inspection expertise and resources.
Back in June, the European Commission confirmed that the U.S. Food and Drug Administration (U.S. FDA) has sufficient capabilities, capacity and procedures to conduct its own U.S. Good Manufacturing Practice inspections at the EU level. Now, on Nov. 1, the U.S. FDA has confirmed the eligibility of eight EU member states to conduct U.S.-level inspections in their territories: Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom. The remaining other European inspectorates are to be assessed by July 15, 2019.
This is noteworthy, as the U.S. FDA has not historically recognized any other country's inspectorate as equivalent to replace U.S.-owned inspection activities. For Austrian pharmaceutical manufacturers supplying the US market, this means that inspections by the US FDA will then generally only be necessary in the case of approvals (for the US market). This will greatly ease the burden on Austrian companies.
This success was made possible by great joint and overarching efforts in the area of quality, a high degree of maturity of the processes of the Austrian Medicines Agency (AGES Medizinmarktaufsicht/Federal Office for Safety in Health Care), and a great deal of know-how and practical experience of the agency staff in the area of GMP and evaluation of other inspectorates.
Queries:
Dr. Christoph Baumgärtel, Tel.: 050555/36004
E-mail: christoph.baumgaertel@ages.at
