Portugal now part of MRA with FDA

Recommendation

1-2 October 2019
Berlin, Germany

GMP for Medical Devices

After a positive assessment, the US Food and Drug Administration (FDA) has approved Portugal to be fully covered by the current EU-FDA Mutual Recognition Agreement (MRA) of GMP inspections of human manufacturers.

The total number of countries accepted by the FDA is now 15: Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom, Czech Republic, Greece, Austria, Hungary, Romania, Lithuania, Ireland and Portugal.

Other EU member states will be added as their evaluation is completed by the US. According to a previous EMA press release, "Plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track."

Source: EMA Press Release entitled "Portugal to also benefit from EU-US mutual recognition agreement for inspections".