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EU and US reach a milestone in mutual recognition of inspections of medicines manufacturers – implications for QPs

  • 29 августа 2019
  • agreement, batch, consequence, EC, EU, FDA, GMP, human, implication, inspection, manufacturer, manufacturing, medicines, milestone, MRA, Mutual Recognition Agreement, phase, QP, site, testing, transition, US, USA, waiver,

ASE Pharma Solutions

With the recognition by the US Food and Drug Administration (FDA) of Slovakia, the last outstanding EU Member State, the European Union and the United States have now fully implemented the Mutual Recognition Agreement (MRA) for inspections of manufacturing sites for certain human medicines in their respective territories.

It means that the US Food and Drug Administration (FDA) completed its assessment of all 28 EU GMP inspectorates for human medicines, confirming that they have the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the US ( to check particular dates for each Member State please refer to the table below).


Member State(s)

1 November 2017

Austria, Croatia, France, Italy, Malta, Spain, Sweden and United Kingdom

1 March 2018

Czech Republic, Greece, Hungary and Romania

1 June 2018

Ireland and Lithuania

14 September 2018


16 November 2018

Belgium, Denmark, Finland and Latvia

28 November 2018


7 February 2019

Poland and Slovenia

29 April 2019

Bulgaria and Cyprus

10 June 2019

Luxembourg and the Netherlands

26 June 2019


11 July 2019


It should be pointed out that the European Commission confirmed in June 2017 that the US FDA has the capability, capacity and procedures in place to carry out GMP inspections for human medicines at a level equivalent to the EU.

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The transition phase for human medicines covered by the agreement ended on 11 July 2019 and as a consequence, a batch testing waiver also starts to apply. This means that the qualified persons in the EU Member States do not need to batch test human medicines covered by the MRA, provided that they have verified that these controls have been carried out in the United States for products manufactured in and imported from the United States.

The Mutual Recognition Agreement implementation work will continue with view to expanding the operational scope to veterinary medicines, human vaccines and plasma derived medicinal products.

European Commission – Press release can be reached here.

Source: EMA, EC