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:
- Confidentiality arrangement enabling the FDA to share full inspection reports of medicine manufacturers, including trade secret information with EU regulators.
- Statement of authority and confidentiality commitment from the EMA not to publicly disclose non-public information shared by the US FDA (15/09/2010)
- Statement of authority and confidentiality commitment from the US FDA not to publicly disclose non-public information shared by the EMA (15/09/2010)
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.
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:
- Renewal of confidentiality arrangement - Letter from European Commission and EMA
- Renewal of confidentiality arrangement - Letter rom MHLW and PMDA
Extension of confidentiality arrangement 2012:
- Extension of confidentiality arrangement - Letter from European Commission and EMA
- Extension of confidentiality arrangement - Letter from MHLW and PMDA
Confidentiality arrangement 2007:
- Confidentiality arrangement - Letter from European Commission and EMA
- Confidentiality arrangement - Letter from MHLW and PMDA
The EU and Switzerland has an MRA in place on good manufacturing practice (GMP) compliance as well as a the following confidentiality arrangement:
- Administrative arrangements to exchange non-public information on medicinal products between DG SANTE-EMA and Swiss FDHA-Swissmedic (22/7/2015)
- Reply to the administrative arrangements to exchange non-public information on medicinal products between DG SANTE-EMA and Swiss FDHA-Swissmedic (22/7/2015)
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.
- EU Adoption decision
- Sectoral Annex on medicinal products, GMP inspection and batch certification - Operation of the Annex with respect to active pharmaceutical ingredients for medicinal products for human use (March 2013)
- Mutual Recognition Agreement in relation to conformity assessment, certificates and markings between the European Community and Australia
- Mutual Recognition Agreement of conformity assessment, certificates and markings - Sectoral annex
Confidentiality arrangements are also in place:
- Confidentiality arrangement: Letter from EMA to TGA of the Australian Government Department of Health and Ageing (1/10/2012)
- Confidentiality arrangement: Letter from TGA of the Australian Government Department of Health and Ageing to EMA (1/10/2012)
The EU and New Zealand has an MRA on GMP compliance in place.
The Agreement between Israel and the EU on Conformity Assessment and Acceptance of Industrial Products (ACAA) entered into force on 19 January 2013.
- EU Adoption Decision OJ L1/1 of 4.1.2013
- Implementation of ACAA - Information sheet
- List of Responsible Authorities for each of the Member States of the EU in the area of Pharmaceutical Good Manufacturing Practice under the ACAA
- Agreement between Israel and the EU on conformity assessment and acceptance of industrial products : Questions and answers
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.
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.
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:
- Letter on the working arrangement to exchange non-public information on medical products between the European Commission's DG SANTE, EMA and the WHO
- WHO confirmation letter on the working arrangement to exchange non-public information on medical products between the European Commission's DG SANTE, EMA and the WHO)
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.
PIC/S - Pharmaceutical Inspection Co-operation Scheme
DG SANTE cooperates with PIC/S and has a co-operation arrangement and a confidentiality arrangement in place: