Germany Joins EU-US Inspections MRA
Executive Summary
There is now only one country left to join the agreement between the EU and the US on recognizing the findings of inspectorates in each other’s jurisdictions.
Germany has now joined the EU-US mutual recognition agreement (MRA) on manufacturing inspections, meaning that the initiative now includes the US and 27 of the 28 EU member states, with only Slovakia still to join.
The MRA was formed by the EU and the US in 2017 to recognize the findings of inspectorates in each other’s jurisdictions.
Member states and the European Medicines Agency have been able to rely on inspection results from the US Food and Drug Administration under the MRA since November 2017, after the European Commission confirmed that the FDA was capable of carrying out good manufacturing practice (GMP) inspections at a level equivalent to the EU.
The FDA has been assessing the GMP capabilities of each member state authority individually for some time now. It has so far confirmed the GMP capability of 27 member states. The plan is for the MRA to become operational in all 28 member states by 15 July. (Also see "More Countries Join US-EU Inspections Deal" - Pink Sheet, 13 Jun, 2019.)
The MRA is designed to help the EU and US regulators strengthen reliance on each other's inspection expertise and resources, allowing them to focus their inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for use in their markets are manufactured. They also expect to be able to prioritize inspections of manufacturing sites for higher-risk cases, and to improve their ability to identify and address potential problems at manufacturing sites before they become a public health risk.
The MRA could also reduce the administrative burden and costs of duplicative inspections for pharmaceutical manufacturers, particularly smaller producers.