The United States (US) Food and Drug Administration (FDA) has confirmed that it will accept good manufacturing practice (GMP) inspections performed by Czech Republic, Greece, Hungary and Romania. There are now 12 Member States whose inspection results the FDA can rely on to replace their own inspections, showing that the mutual recognition agreement between the EU and the US to recognise inspections of manufacturing sites for human medicines conducted in their respective territories is progressing as planned. Back in November 2017, the FDA confirmed the capability of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and United Kingdom. It is expected that the agreement will be operational in all EU Member States by 15th July 2019.
The European Commission has confirmed that the FDA is capable, and has the capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. Since 1st November, EU Member States can rely on inspection results from the FDA to replace their own inspections. There are mutual benefits for authorities and industry including less duplication, a better use of their inspection resources to focus on sites of higher risk and reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.
To read more about the EU-US mutual recognition agreement for inspections, please click here.
To view the questions and answers document on the impact of the mutual recognition agreement between the EU and the US as of 1st March 2018, please click here.