US Yes To Two More Countries Under EU Inspections Deal
Executive Summary
The US drug regulator may now rely on a total of 22 EU member states whose inspection results can replace its own inspections.
Another two countries, Poland and Slovenia, have now been included in the mutual recognition agreement (MRA) that the EU and the US formed in 2017 to recognize the findings of inspectorates in each other’s jurisdiction.
The new additions, announced by the European Medicines Agency this month, brings to 22 the total number of EU member states whose good manufacturing practice (GMP) inspections the US Food and Drug Administration can rely on in place of its own inspections.
Member states and the European Medicines Agency have been able to rely on inspection results from the FDA under the MRA since November 2017, following the European Commission’s confirmation that the US agency was capable of carrying out GMP inspections at a level equivalent to the EU.
The FDA has been assessing the GMP capabilities of each member state authority individually. In addition to Poland and Slovenia, the other member states that the FDA has so far confirmed are capable of conducting GMP inspections equivalent to those of the US and whose inspections can replace its own inspections are: Austria, Belgium, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Ireland, Latvia, Lithuania, Malta, Portugal, Romania, Spain, Sweden and the UK.
The plan is for the MRA to become operational in the remaining six member states by July 15, 2019. The EMA said that this was still on track.
The MRA is designed to help the EU and US regulators strengthen reliance on each other's inspection expertise and resources. By doing so, they believe they will be able 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 improve their ability to identify and address potential problems at manufacturing sites before they become a public health risk.
The MRA can also reduce the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.
Last May, the EMA reported that European health authorities were conducting fewer GMP inspections at facilities regulated under the EU’s centralized marketing procedure thanks to the MRA. (Also see "EMA Reports Sharp Reduction In EU GMP Inspections Last Year" - Pink Sheet, 3 May, 2018.)
From the editors of Scrip Regulatory Affairs.