US and EU sign milestone mutual recognition agreement

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US and EU sign milestone mutual recognition agreement

INICIO/Políticas y legislación | Posted 17/01/2020 0 Post your comment

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have signed a historic mutual recognition agreement which means the US will now recognize the good manufacturing practice (GMP) inspections of all EU Member States, and vice versa.

The mutual recognition agreement, which was finally reached in 2019, applies to inspections of manufacturing sites of human medicines. Previously, authorities from the EU and US have needed to inspect each other’s production sites individually to ensure they are GMP compliant.

Now, the regulators will be able to rely on each other’s inspections for human medicines, which will avoid the duplication of inspections. The agreement will also free up resources for the inspection of facilities in other countries, say EMA.

Executive Director of EMA Guido Rasi welcomed the agreement: ‘This milestone is a testimony to the importance of our strategic partnership with the US. It will support making best use of our inspection capacity, so that patients can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured.’

The agreement is based on evidence that the EU and US use comparable procedures for carrying out GMP inspections and involved audits of the respective regulatory agencies ongoing since 2014.

EMA and FDA announced back in March 2017 that they had agreed to recognize 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 [2]. Since then, the rest of the EU Member States have assessed and added to the agreement. The final Member State to be positively assessed was Slovakia, concluding the audits of GMP inspectorates covering human medicines.

The agreement includes a batch testing waiver, which means that pharmaceutical manufacturers in the EU will no longer need to carry out quality checks of products manufactured in the US.

In the future, the mutual recognition agreement looks to be extended to include human vaccines, plasma-derived medicinal products (biological drugs such as antibodies) and veterinary medicines.

Bulgaria and Cyprus added to EU-US mutual recognition agreement

Two more countries added to EU-US mutual recognition agreement

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 2020 Jan 17]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-to-recognize-GMP-inspections
2. 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 2020 Jan 17]. Available from: www.gabionline.net/Policies-Legislation/Five-more-countries-added-to-EU-US-mutual-recognition-agreement

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Source: European Medicines Agency