
Portugal to Benefit from EU-US Mutual Recognition Agreement for Inspections
The agreement now includes 15 European Union (EU) member states.
On Sept. 20, 2018, the European Medicines Agency (EMA) reported that the
In
EMA states that plans for the agreement to be operational in all EU member states by July 15, 2019 are on track, and that the agreement is supported by evidence that both the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission (EC), EU national competent authorities, EMA, and FDA have been auditing and assessing the respective supervisory systems since May 2014 and are working closely together to reach the agreement’s milestones, according to EMA.
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