At a bilateral meeting held on 18−19 June 2018, representatives from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) discussed further opportunities for collaboration.

The aim of the meeting was to review their ongoing cooperative initiatives, discuss strategic priorities for the coming years and further strengthen the continuous close collaboration with specific action in the field of pharmaceuticals. Representatives discussed the two agencies’ mutual recognition agreement (MRA) that took effect in November 2017 [1], allowing the institutions to recognize one another’s manufacturing site inspection outcomes. Other subjects discussed included advanced therapy medicinal products (ATMPs), e.g. gene therapies, tissue engineered products and somatic cell therapies), generics and real-world evidence (RWE), which has been used for the post-authorization monitoring of medicines for many years.

The parties agreed to encourage early parallel scientific advice and to further strengthen the existing ‘cluster’ on ATMPs with a view to develop common scientific approaches on the regulation of these medicine. They also agreed on continued access for companies to EMA−FDA parallel scientific advice and further collaboration between regulators on the product-specific guidelines they develop for generics.

The two agencies also confirmed their intention to consider including veterinary medicines in the scope of the MRA no later than July 2019 and vaccines and plasma-derived pharmaceuticals no later than July 2022.

Then on 18 July 2018, EMA announced that the EU and Japan have agreed to expand the range of medicines for which they will mutually recognize each other’s good manufacturing practice (GMP) inspections of manufacturing sites.

The current MRA between the EU and Japan has been operational since 29 May 2004. The scope of this agreement has now been expanded to cover sterile drugs, certain biological medicines including vaccines and immunologicals, and active pharmaceutical ingredients for any drug covered in the agreement.

In the EU, inspections of manufacturing sites are carried out by national competent authorities from EU Member States. In Japan, GMP inspections are conducted by the Pharmaceuticals and Medical Devices Agency and the 47 inspectorates of the prefectures.

Japan also recognized as equivalent all EU competent authorities for human medicines inspection.

Related article
EMA and FDA to recognize GMP inspections

Reference
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 Aug 31]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-to-recognize-GMP-inspections

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