01 Nov MRA between USA and EU – Austrias CA among the first positively evaluated CAs
From 01.11.2017 parts of the mutual recognition agreement (MRA) between USA and EU have entered into force (link) covering the mutual recognition of GMP inspections in order to help to make better use of inspection capacity and reduce duplication. EU and US regulators will rely on each other’s inspections in their own territories. In future, the need for an EU authority to inspect a site located in the US, or vice versa, will be limited to exceptional circumstances – for ratified countries.
The US-FDA has evaluated several EU-Competent Authorities. The eligibility of 8 EU CAs has been ratified: The Austrian Federal Office for Safety in Health Care has been among these first 8 CAs – beside Croatia, France, Italy, Malta, Spain, Sweden and UK, which were considered to perform inspections equivalent to FDA-level. Further EU CAs are going to be evaluated until July 15th 2019.
Further information can be found also on the AGES-Homepage (link, in German).