Five more countries added to EU-US mutual recognition agreement

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Five more countries added to EU-US mutual recognition agreement

INICIO/Políticas y legislación | Posted 14/12/2018 0 Post your comment

The European Medicines Agency (EMA) announced on 29 November 2018 that the Mutual Recognition Agreement between the European Union and the US had been extended to include five additional EU Member States, Belgium, Denmark, Estonia, Finland and Latvia.

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, Spain, Sweden and the UK, 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; Portugal was added on 20 September 2018, bringing the total to 15 EU Member States [2].

Belgium, Denmark, Finland and Latvia were included into the mutual recognition agreement between the EU and the US on 16 November and Estonia on 28 November 2018.

In June 2017, the European Commission 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.

EMA says that the agreement ‘strengthens reliance on each other's inspection expertise and resources’. The agency also says the mutual benefits for EU authorities and FDA include:

the ability to focus inspection resources on other parts of the world where active pharmaceutical ingredients and medicines for the EU or US markets are manufactured
prioritizing inspections of medicines manufacturing sites for higher risk cases
reassuring patients that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured
improving the ability to identify and address potential problems at manufacturing sites before they become a public health risk
reducing the administrative burden and costs from duplicative inspections for pharmaceutical manufacturers, including smaller producers.

EMA also says that ‘plans for the agreement to be operational in all EU Member States by 15 July 2019 are on track’.

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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 2018 Dec 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 2018 Dec 14]. Available from: www.gabionline.net/Policies-Legislation/EU-US-mutual-recognition-extended-to-include-Portugal

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Source: EMA