International – Questions & Answers on the impact of Mutual Recognition Agreement between the European Union and the United States

Q1: What is in place since 1 November 2017?

A1: The provisions of the agreement relating to the mutual recognition of inspections took effect on 1 November 2017. This milestone followed the confirmation, in June 2017, by the European Commission (EC) that the US Food and Drug Administration (FDA) has the capability, capacity and procedures in place to carry out good manufacturing practice (GMP) inspections at a level equivalent to the European Union (EU) and on 1 November, the confirmation by the FDA of the capability of eight Member States – Austria, Croatia, France, Italy, Malta, Spain, Sweden and United Kingdom. FDA confirmed the capability of the other Member States on:

 1 March 2018: Czech Republic, Greece, Hungary and Romania;
 1 June 2018: Ireland and Lithuania;
 14 September 2018: Portugal;
 16 November 2018: Belgium, Denmark, Finland and Latvia;
 28 November 2018: Estonia;
 7 February 2019: Poland and Slovenia;
 29 April 2019: Bulgaria and Cyprus;
 10 June 2019: Luxembourg and the Netherlands;
 26 June 2019: Germany;
 11 July 2019: Slovakia.

Q2: Does this Mutual Recognition Agreement mean that from 1 November 2017 EU and US regulators will stop conducting GMP inspections in each other’s territories?

A2: As of 1 November 2017, the EU Member States will not duplicate inspections conducted by the FDA. At the same time, it is expected that the FDA will not duplicate inspections conducted by a recognised authority
.
Exceptionally, both the EU and FDA reserve the right to inspect in each other’s territory at any time…