International cooperation

Bilateral relations on pharmaceutical cooperation

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The EU has entered into a number of mutual recognition agreements (MRA) on Good Manufacturing Practices (GMP) as well as confidentiality arrangements with some partners around the world.

United States of America

The European Commission, the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) have been collaborating at technical and scientific level for many years in the sector of pharmaceuticals.

A MRA between EU and US on pharmaceutical GMP inspections has been in force since November 2017 and will remain in transition until July 2019. It aims to encourage greater harmonisation of procedures, make better use of inspection capacity, reduce duplication of inspections, and focus on markets that pose a greater risk.

Confidentiality arrangements are also in place:

Canada

In 2003 the EU and Canada entered an operational Mutual Recognition Agreement (MRA) This MRA was suspended and incorporated in a Comprehensive Economic and Trade Agreement (CETA) which entered into provisional application on 21 September 2017.

The MRA sectoral Annex on GMP for pharmaceuticals has been incorporated into CETA under the Protocol on the Mutual Recognition of the Compliance and Enforcement Programs regarding Good Manufacturing Practices (GMP) for Pharmaceutical Products.

In this context, six Administrative Arrangements were established by DG Health & Food Safety and Health Canada as required by the Protocol on the Mutual Recognition of the Compliance and Enforcement Programme regarding Good Manufacturing Practices for Pharmaceutical Products.

Japan

The EU and Japan have an MRA on GMP in place as well as a confidentiality arrangement. The expansion of operational product scope of the Sectoral Annex on GMP was adopted in June 2018.  

Renewal of confidentiality arrangement 2013:

Extension of confidentiality arrangement 2012:

Confidentiality arrangement 2007:

Switzerland

The EU and Switzerland has an MRA in place on good manufacturing practice (GMP) compliance as well as a the following confidentiality arrangement:

Australia

The EU and Australia have an MRA on GMP compliance, and confidentiality arrangement in place. An amendment to the MRA entered into force in January 2013.

Confidentiality arrangements are also in place:

New Zealand

The EU and New Zealand has an MRA on GMP compliance in place.

Israel

The Agreement between Israel and the EU on Conformity Assessment and Acceptance of Industrial Products (ACAA) entered into force on 19 January 2013.

China

The Commission and the State Food and Drug Administration of the People's Republic of China jointly established an EU-China consultation and cooperation mechanism in 2010 with the aim of promoting information exchange, mutual understanding on pharmaceuticals, medical devices, cosmetics and related administrative regulatory scientific matters. Under this mechanism DG SANTE, in close collaboration with EMA, has established a Regulatory Dialogue with CFDA (China Food and Drug Administration) which allows the two parties to discuss issues related to pharmaceuticals.

India

The EU engages in regulatory dialogue with India via the EU-India Joint Working Group on Pharmaceuticals, Biotechnology and Medical Devices. Collaboration is based on the 1994 Cooperation Agreement on Partnership and Development.

Russia

The 2010 Russia and EU Partnership for Modernisation document sets the priorities and the scope for intensified cooperation. Cooperation on medicinal products is dealt with by the Sub-Group on Pharmaceuticals of the Health dialogue.

With respect to clinical trials, the 2012 analytical report Cooperation in the field of clinical trials provides recommendations on how to address the differences between the EU and Russian Federation.

WHO - World Health organization

DG SANTE cooperates with the World Health Organisation (WHO) and has a confidentiality arrangement  in place:

EDQM - European Directorate for the Quality of Medicines

DG SANTE cooperates with the European Directorate for the Quality of Medicines and HealthCare (EDQM) and has a confidentiality arrangements in place.