06.03.2017
To the attention of interested persons
The National Agency for Medicines and Medical Devices (NAMMD), member of the European network of National Competent Authorities (NCAs) coordinated by the European Medicines Agency (EMA) expresses its satisfaction due to the agreement signed between regulatory authorities in the EU and the US, concerning mutual recognition of inspections conducted at medicinal product manufacturing sites.
The agreement will enable both the EU authorities and the FDA to make better use of their inspection resources to help them to focus on other parts of the world where active pharmaceutical ingredients and medicinal products for the EU or US markets are manufactured. This will ensure that patients can rely on the quality, safety and efficacy of all medicinal products, no matter where they have been produced.
The agreement is underpinned by robust evidence that the EU and the US have comparable regulatory and procedural frameworks for inspections of manufacturers of human medicines. In this context, it is worth mentioning that the NAMMD complies with the procedural framework imposed by EU legislation for pharmaceutical inspections.
Teams from the European Commission, NCA, EMA and FDA have been audited and assessing the respective supervisory systems since May 2014, and have worked closely together to reach this agreement.
The Agreement is an Annex to the EU-US Mutual Recognition Agreement which was signed in 1998, but is not yet implemented. Many provisions of the agreement have already entered into force and others will enter into force on 1 November 2017. The text of the Agreement is now published on the website of the European Commission’s Directorate General for Trade.