Bulgaria and Cyprus added to EU-US mutual recognition agreement

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Bulgaria and Cyprus added to EU-US mutual recognition agreement

Home/Policies & Legislation | Posted 14/06/2019 0 Post your comment

The European Medicines Agency (EMA) announced on 29 April 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, Bulgaria and Cyprus.

Back in March 2017, EMA and the US Food and Drug Administration (FDA) announced an agreement to recognize good manufacturing practice (GMP) inspections of pharmaceutical manufacturing sites for human medicines conducted in their respective territories [1]. The agreement, according to EMA, is underpinned by robust evidence that the EU and the US have comparable regulatory and procedural frameworks for such inspections. Teams from the European Commission, 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.

The agreement enables EMA and FDA to make better use of their inspection resources including focusing on other parts of the world where medicines are manufactured for the EU or US, prioritising inspections of manufacturing sites for higher risk cases and reducing the administrative burden and costs associated with duplicative inspections.

Eight EU Member States – Austria, Croatia, France, Italy, Malta, Spain, Sweden and the UK – were included in the original agreement. In March and June 2018, six further EU Member States were recognized by FDA. Portugal was added on 20 September 2018 [2], followed by Belgium, Denmark, Finland and Latvia on 16 November and Estonia on 28 November [3]. On 11 February 2019, Poland and Slovenia were added [4]. The addition of Bulgaria and Cyprus brings the total EU Member States included in the MRA between the EU and the US to 24.

According to EMA, the planned date for the agreement to be operational in all EU Member States is 15 July 2019.

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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 Jun 14]. 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 Jun 14]. 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 Jun 14]. Available from: www.gabionline.net/Policies-Legislation/Five-more-countries-added-to-EU-US-mutual-recognition-agreement
4. GaBI Online - Generics and Biosimilars Initiative. Two more countries added to EU-US mutual recognition agreement [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from: www.gabionline.net/Policies-Legislation/Two-more-countries-added-to-EU-US-mutual-recognition-agreement

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Source: EMA