Relations of the European Union with Third countries

The European Union and the United States of America

The European Commission, the European Medicines Agency (EMEA) and the US Food and Drug Administration (FDA) have been collaborating for many years in the sector of pharmaceuticals. This collaboration takes the form of multilateral work, including the International Conference on Harmonisation ( ICH), and bilateral work. The bilateral work intensified in 2003 with the establishment of confidentiality arrangements between the partiespdf(48 KB) . Under these confidentiality arrangements, regulatory and scientific collaboration has intensified in breadth and scope year on year.

The objectives of the confidentiality arrangements are to further enhance and strengthen communication and further enhance public health promotion and protection in the European Union and in the United States of America. More specifically, the initiative sets out to promote and protect public health, reducing regulatory burdens and costs, and bringing innovative products to patients in a timely manner. Furthermore, important safety information about medicinal products is shared among the parties.

The types of information that may be shared include, but are not limited to, the following:

  • Drafts of pending laws, regulations, guidance documents, procedures and other technical documents available to the individual participants related to pharmaceutical products.
  • Post-marketing data and information that could have an impact on public health, such as pharmacovigilance data or information about impending regulatory actions.
  • Information on quality defects or product recalls of pharmaceutical products known by the FDA to have been manufactured or distributed in the EU, and vice versa.
  • Information contained in or related to marketing or investigational applications for human or animal pharmaceutical products. This includes information on maximum residue levels in these applications.
  • Information related to orphan drug designations.
  • Inspection reports and product sample test results describing the compliance of a pharmaceutical product or manufacturing facility with regulatory requirements.
  • Good Clinical Practice (GCP) inspection reports of clinical trial sites.
  • Information technology information supporting the regulatory process.

In 2007 further momentum was given to regulatory collaboration by the ' Framework for Advancing Transatlantic Economic Integration between the European Union and the United States of America'.

The EU-US Framework for Advancing Transatlantic Economic Integrationpdf provides a platform to facilitate upstream regulatory cooperation and launch concrete competitiveness-oriented initiatives, such as the Transatlantic Workshop on Administrative Simplification in Medicines Regulation. EU-US upstream regulatory cooperation will provide opportunities for simplification and convergence of the regulatory frameworks, thereby bringing closer the two biggest pharmaceutical markets in the world and reducing costs by eliminating unjustified regulatory divergences. Joint initiatives with other third countries aiming in the same direction could also be developed on specific issues..

  • 29/07/2011
    Transatlantic Administrative Simplification Action Plan – Final Report on implementation
    During the annual EC/EMA-FDA bilateral meeting in September 2010, the parties updated on the progress with implementation of the administrative simplification projects as outlined in the table below and agreed that ongoing developments in these areas and/or new transatlantic administrative simplification initiatives will be included in the annual report on EMA-FDA interactions.

    The Final Report can be accessed herepdf(141 KB) .

  • 22/10/2009

    Transatlantic Administrative Simplification Action Plan – 2009 implementation report

    During the recent annual EU-EMEA/FDA bilateral meeting the parties updated on the progress with implementation of the Transatlantic Administrative Simplification Action Plan, agreed in June 2008.

    The action plan can be accessed herepdf(52 KB) .

  • 7/10/2008

    Press release: EC/EMEA/FDA bilateral meeting

    The European Commission (EC), the European Medicines Agency (EMEA) and the United States Food and Drug Administration (FDA) met in London on 30 September and 1 October 2008 for the annual review of cooperative activities undertaken within the scope of their confidentiality arrangements. A joint press release can be accessed herepdf(42 KB) .
  • 17/06/2008

    Medicines Regulation: Transatlantic Administrative Simplification Action Plan

    Under the auspices of the Transatlantic Economic Council, on 28 November 2007 the European Commission hosted the Transatlantic Administrative Simplification Workshop which was co-chaired by the European Commission and the United States (US) Food and Drug Administration (FDA) and organised in collaboration with the European Medicines Agency (EMEA) and the Heads of the EU National Medicines Agencies (HMA).

    As a follow-up to the workshop the European Commission DG Enterprise and Industry and the US FDA (in collaboration with EMEA and national medicines agencies) agreed the action plan which can be accessed herepdf(42 KB) .
  • 13/05/2008

    Transatlantic Economic Council notes strengthened collaboration on medicines regulation

    For more information, please consult the International relations - Key documents section
  • 30/11/2007

    Transatlantic Cooperation in Pharmaceutical Regulation: Identifying Opportunities for Administrative Simplification

    In Brussels on 28 November 2007, in the field of pharmaceutical regulation, the European Commission hosted the Transatlantic Administrative Simplification Workshop, which was co-chaired by the European Commission and the United States (US) Food and Drug Administration (FDA) and organised in collaboration with the European Medicines Agency (EMEA) and the Heads of the EU National Medicines Agencies (HMA). For more information, please consult the joint announcementpdf(34 KB) .
  • 18/06/2007

    Transatlantic Cooperation on Medicines Regulation expanded

    On 14 and 15 June the bilateral meeting between the European Commission and European Medicines Agency and the United States Food and Drug Administration made important progress on expanding transatlantic regulatory cooperation.

    Joint press releasepdf(30 KB)

    'Principles for Interaction' on medicines for childrenpdf(42 KB)

    Revised implementation planpdf(48 KB)

Documents

The European Union and Canada

The EU and Canada have been working collaboratively for many years in the area of medicines and therapeutic product regulation. This has included a mutual recognition agreement on manufacturing of medicines, through the International Conference on Harmonisation (ICH) and the International Conference on Harmonisation of Technical Requirements for Registration of Veterinary Products (VICH).

Confidentiality arrangements in the area of medicines and therapeutic product regulation were agreed between the European Commission and the European Medicines Agency (EMEA) on the one hand and the Health Products and Food Branch of Health Canada on the other at a bilateral meeting in Brussels in December 2007.

The new confidentiality arrangements build on the previous cooperation and will allow exchanges of information between the parties as part of their regulatory and scientific processes, both before and after a medicine has been approved.

The regulatory experts from the European Union and Canada will from now on be able to exchange confidential information about the authorisation and safety of medicines. The partners will be able to exchange confidential information, for instance on safety issues with marketed medicines and therapeutic products being developed or considered for authorisation.

This closer cooperation between the authorities will provide earlier access to information and thus make it easier and quicker to take action to protect public health. Sharing information and expertise will help both the Canadian and EU authorities to further strengthen public health protection.

The types of information covered include:

  • position papers on future legislation and/or regulatory guidance documents;
  • scientific advice on product development given to companies to promote innovation;
  • assessments of applications for marketing authorisations; and
  • information about the safety of marketed medicines to better protect public health.

The potential benefits of this exercise are expected to include:

  • accelerated access of patients to new and innovative medicines;
  • improved performance and safety as a result of the involvement of the best available regulatory expertise from both the EU and Canada.

April 2009 : European Commission, European Medicines Agency and Health Canada implementation plan for confidentiality arrangement

The European Commission, together with the European Medicines Agency and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement, signed in December 2007.

The implementation plan details the process for both regular and ad-hoc exchanges of information and describes the process for monitoring the progress of the implementation plan.

The implementation plan can be found here :

English versionpdf(87 KB) - Version françaisepdf(88 KB)

Documents

The European Union and Japan

The European Union and Japan have been collaborating in the area of human medicines regulation for many years. This has included a mutual recognition agreement on the manufacturing of medicines, through the International Conference on Harmonisation (ICH) and bilateral meetings. Since 2007 arrangements to exchange confidential information are agreed between the European Commission and the European Medicines Agency on one hand and the Japanese Ministry of Health, Labour and Welfare (MHWLW) and the Japanese Pharmaceuticals and Medicinal Devices Agency (PMDA) on the other.

The arrangements are similar to the ones that the EU has concluded with the United States and will allow for the exchange of confidential information about the authorisation and safety of medicines between the two countries before and after a medicine has been approved.

The type of information that can be exchanged includes, but is not limited to:

  • advance drafts of legislation and /or regulatory guidance documents;
  • scientific advice on product development given to companies to promote innovation;
  • assessment of applications for marketing authorisations;
  • information about the safety of marketed medicines to better protect public health.

The arrangements should accelerate access of patients to new and innovative medicines, reduce regulatory burdens and costs, and improve performance and safety as a result of the involvement of the best available regulatory expertise from both the EU and Japan.

Documents

The European Union and India

The European Union is engaged in a regulatory dialogue with India. For this purpose an India-EC Joint Working Group on Pharmaceuticals and Biotechnology has been set up. Collaboration in medicinal products is based on the Co-operation Agreement between the European Community and India on Partnership and Development of 1994, which provides for specialised sub-groups.

Technical regulations and standards as well as intellectual property rights are important issues dealt with by this Working Group, which is established to deepen dialogue on pharmaceuticals and biotechnologies related to healthcare with a view to facilitating bilateral trade and increasing market access. The Working Group will strive to promote the protection of public health in the EU and India through the sharing of legislation, guidelines and experiences in pharmaceutical and biotechnology regulation.

The European Union and Russia

Leaders of Russia and the EU signed a joint statement on "Partnership for Modernization" in June 2010. The document sets the priorities and the scope for intensification of cooperation in the interests of modernization between Russia and the European Union (for more information, see: http://formodernisation.com/en/info/). This partnership is structured in a series of sectorial dialogues.

Co-operation on medicinal products is specifically considered in the Sub-Group on Pharmaceuticals of the Health dialogue.

The current activities of this subgroup is focussed on important issues such as:

  • Legislation relevant to medicinal products;
  • Clinical trials;
  • Pharmacovigilance;
  • Orphan products and biosimilars;
  • GMP and details of registration procedures.

With respect to clinical trials, the analytical report entitled "Cooperation in the field of clinical trials "pdf(2 MB) was finalised in September 2012. The main conclusion of the report is that "In general, it can be stated that for the conduct and supervision of clinical trials in the EU and the RF equivalence of the respective regulatory/legislative framework provisions is given". The report also provides recommendations on how to address the differences between the EU and Russian Federation in identified in the four following categories:

  • differences that might affect the trial participant's rights, safety and welfare, credibility of study data carried out in the Russian Federation and thus acceptance of the clinical study results by the DRAs in the EU;
  • differences, which restrict the nature and extent of trials that can be carried out in the Russian Federation, in a manner more restrictive than those in the EU;
  • specific requirements of the Russian Federation that go beyond those applied in the EU;
  • other, country-related, differences.

The European Union and China

The Commission and the State Food and Drug Administration of the People's Republic of China have to set up an EU-China Consultation and Cooperation Mechanism with the aim of promoting information exchange, mutual understanding on pharmaceuticals, medical devices, cosmetics and related administrative regulatory scientific matters.

The European Union and Switzerland, Australia and New Zealand

The European Union has been collaborating in the area of medicinal products with Australia, New Zealand and Switzerland. This collaboration has taken the form of mutual recognition in relation to conformity assessment with Switzerland and New Zealand and of mutual recognition in relation to conformity assessment, certificates and markings with Australia.

Documents

European Community (EC) and Switzerland

European Community (EC) and Australia

European Community (EC) and New Zealand