Two more countries added to EU-US mutual recognition agreement

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Two more countries added to EU-US mutual recognition agreement

Home/Policies & Legislation | Posted 08/03/2019 0 Post your comment

The European Medicines Agency (EMA) announced on 11 February 2019 that the mutual recognition agreement (MRA) between the European Union (EU) and the US had been extended to include two additional EU Member States, Poland and Slovenia.

An agreement to recognize good manufacturing practice (GMP) inspections of pharmaceutical manufacturing sites conducted in Europe and the US was made by EMA and the US Food and Drug Administration (FDA) announced back in March 2017 [1].

The agreement, according to EMA, 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 (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.

In June 2017, the EC confirmed that FDA has the capability, capacity and procedures in place to carry out GMP inspections at a level equivalent to the EU. 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.

Eight EU Member States – Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – that would be recognized by FDA were included in the original agreement. On 1 March 2018, four more EU Member States were recognized by FDA, and on 1 June 2018 two more were added. Portugal was added on 20 September 2018 [2], followed by Belgium, Denmark, Finland and Latvia on 16 November and Estonia on 28 November 2018 [3].

The addition of Poland and Solvenia brings the total EU Member States included in the MRA between the EU and the US to 22.

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References
1. GaBI Online - Generics and Biosimilars Initiative. EMA and FDA to recognize GMP inspections [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-to-recognize-GMP-inspections
2. GaBI Online - Generics and Biosimilars Initiative. EU-US mutual recognition extended to include Portugal [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 8]. Available from: www.gabionline.net/Policies-Legislation/EU-US-mutual-recognition-extended-to-include-Portugal
3. GaBI Online - Generics and Biosimilars Initiative. Five more countries added to EU-US mutual recognition agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Mar 9]. Available from: www.gabionline.net/Policies-Legislation/Five-more-countries-added-to-EU-US-mutual-recognition-agreement

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Source: EMA