EU-US mutual recognition extended to include Portugal

Home/Policies & Legislation | Posted 02/11/2018 post-comment0 Post your comment

The European Medicines Agency (EMA) announced on 20 September 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include one additional EU Member State, Portugal.

Review committee V15a16

EMA and the US Food and Drug Administration (FDA) announced back in March 2017 that they had agreed to recognize good manufacturing practice (GMP) inspections of pharmaceutical manufacturing sites conducted in their respective territories [1].

The original agreement included eight EU Member States – Austria, Croatia, France, Italy, Malta, the UK, Spain and Sweden that would be recognized by FDA. Four further EU Member States were recognized by FDA on 1 March 2018 and two on 1 June 2018. With the addition of Portugal, this has now been extended to include 15 EU Member States.

Since 1 November 2017, it has been recognized that the EU Member States and EMA can rely on inspection results from FDA to replace their own inspections. The plans for the agreement to be operational in all EU Member States by 15 July 2019 is also ‘on track’, according to EMA.

EMA said that ‘the agreement is underpinned by robust evidence on both sides of the Atlantic that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. Teams from the European Commission, EU national competent authorities, EMA and the FDA have been auditing and assessing the respective supervisory systems since May 2014; and are working closely together to reach the agreement’s milestones’.

EMA has also announced in July 2018 that the EU and Japan have agreed to expand the range of medicines for which they will mutually recognize each other’s GMP inspections of manufacturing sites [2].

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1. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA to recognize GMP inspections []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. EU reinforces collaborations with US and Japan []. Mol, Belgium: Pro Pharma Communications International; [cited 2018 Nov 2]. Available from:

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Source: EMA

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