20/21 December 2022
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."