IPRP expands and all EU Member States now included in EU-US MRA

Home/Policies & Legislation | Posted 16/08/2019 post-comment0 Post your comment

During the June 2019 International Pharmaceutical Regulators Programme (IPRP) management committee meeting in Amsterdam, The Netherlands, it was announced that Iran’s National Regulatory Authority (NRA) and Argentina’s National Administration of Drugs, Foods and Medical Devices (ANMAT – Administración Nacional de Medicamentos, Alimentos y Tecnología Médica) have joined the IPRP. There are now 26 members of IPRP. 

Regulation V13H16

The meeting saw Dr Junko Sato of Japan’s Ministry of Health, Labour and Welfare and Ms Hacer Coşkun Çetintaş from the Turkish Medicines and Medical Devices Agency (TİTCK) be elected as chair and vice chair of the management committee. In addition, there were discussions about generics and biosimilars, and regulatory frameworks.

In July 2019, the US Food and Drug Administration (FDA) and the European Union (EU) announced that they have now fully implemented the mutual recognition agreement (MRA) for inspections of manufacturing sites for certain human medicines in their territories. Following FDA assessment, Slovakia was the final EU Member State to be included in the agreement.

The agreement to recognize good manufacturing practice (GMP) inspections of pharmaceutical manufacturing sites conducted in Europe and the US was initially announced in March 2017 [1]. However, at this time not all EU Member States had been assessed by FDA. Now that all EU Member States have been included, the agreement ensures that authorities in the US and across the EU can rely on each other’s inspection results for human medicines and avoid duplicating inspections. Patients can be assured that they can rely on the quality, safety and efficacy of all medicines, no matter where they have been manufactured.

A batch testing waiver will now also apply. Here, EU pharmaceutical companies will no longer have to carry out quality controls for US products when these controls have already been carried out in the US. In the future, the MRA is likely to expand to veterinary medicines, human vaccines and plasma-derived medicinal products.

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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 2019 Aug 16]. Available from: www.gabionline.net/Policies-Legislation/EMA-and-FDA-to-recognize-GMP-inspections

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