EU-US Mutual Recognition Agreement on Inspections: Four Member States Added
Posted 01 March 2018 | By
The European Medicines Agency (EMA) on Thursday announced that the US Food and Drug Administration (FDA) has confirmed the capabilities of regulators in the Czech Republic, Greece, Hungary and Romania to participate in a mutual recognition agreement focused on drug manufacturing inspections.
Under the agreement, FDA can now rely on inspections conducted in 12 member states (the first eight were added in October 2017
– Austria, Croatia, France, Italy, Malta, Spain, Sweden and UK) to replace its own inspections. EMA said that plans are still on track for the mutual recognition agreement to be operational in all member states by 15 July 2019.
Since 1 November 2017, EU member states can rely on inspections from FDA to replace their inspections.
“Around 40% of finished medicines marketed in the EU come from overseas and, for around 85% of medicines sold in the EU, at least one manufacturing step takes place outside the Union,” EMA said
Mutual benefits under the agreement for both EU and FDA authorities, which has been in place
almost exactly a year, include: Avoiding duplicative inspections and reducing the administrative burden and costs, improving the use of inspection resources to focus on manufacturing sites of higher risk, and improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk.