MRA Countdown: 10, 6, 4, 2, ...

Recommendation

28/29 January 2020
Berlin, Germany

Combination Products Medicinal Products/Drugs meet Medical Devices

The Mutual Recognition Agreement (MRA) with the US is on track. In a press announcement from 11 June the EMA informed that Luxembourg and the Netherlands have joined the agreement for good manufacturing practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU Member States.
 
Now 26 countries are included. Germany and Slovakia are the only EU member states that have not been added yet. By 15 July 2019, however, all authorities and countries should have been approved and acknowledged by FDA.
 
If the agreement is in force (and only then!), the additional full testing of a drug imported from the USA will no longer be necessary. This also applies to countries that have already been recognised.

Source: EMA press release entitled "Two additional countries to benefit from EU-US mutual recognition agreement for inspections".