Established in May 2009, the Europe Office serves as the lead for the FDA’s on- site presence in Europe. It covers the European Union and individual countries that are not EU members, such as Switzerland and Norway and facilitates progress on many joint European-U.S. projects spanning the full spectrum of FDA-regulated products. The mission of the Europe Office is to strengthen the safety, quality, and effectiveness of medical products and food produced in Europe for export to the United States. It seeks to achieve those objectives by:
- Fostering collaboration with FDA’s regulatory counterparts to identify opportunities for regulatory alignment, to the extent possible; identifying and analyzing key legislative and policy developments in Europe and then advocating for FDA positions in consultation with Centers and Offices;
- Promoting FDA’s safety and efficacy standards and the advancement of FDA’s international objectives that contribute to improvements in global public health;
- Supporting the U.S. Interagency Mission to the European Union to ensure the coordination of U.S. government activities that are related to FDA equities.
The Europe Office has staff located in:
- Brussels, Belgium, within the US Mission to the European Union;
- Amsterdam, The Netherlands, embedded in the European Medicines Agency (EMA), and;
- White Oak, Maryland, USA, at FDA Headquarters.
Below are examples of Europe Office’s ongoing initiatives and activities.
- Pharmaceutical Mutual Recognition Agreement (MRA) – The culmination of 5 years of close collaboration between FDA, EU and MS, the US and EU may now rely on each other’s pharmaceutical GMP inspections, freeing up valuable regulatory resources. The Europe Office serves a critical role in conducting capability assessments and facilitating other steps necessary to establish and implement MRA processes. For more information about the MRA, see: FDA MRA resource page and FDA Voices blog, “Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators.”
- Shellfish trade – FDA’s final equivalence determination, issued in September 2020, finds that the adoption and implementation by Spain and the Netherlands of the EU’s system of food safety control measures for raw bivalve molluscan shellfish, along with their application of additional measures specifically adopted for export to the United States, are equivalent to comparable U.S. controls. Separately, the European Commission has determined that U.S. controls for bivalve molluscan shellfish are equivalent to comparable EU controls and initially will allow imported molluscan shellfish from listed establishments in Massachusetts and Washington. These actions enable reopening of markets in molluscan shellfish that have been closed to trade between the United States and the EU since 2010. For more information, see: Federal Register Notice and FDA Voices blog, “Equivalence: Using a Trade Mechanism to Ensure Broader Consumer Choice and Open New Markets for Molluscan Shellfish,” and additional resources, International Cooperation on Food Safety.
- European Medical Device Regulation – Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council of April 5, 2017 on in vitro diagnostic (IVD) medical devices entered into force on May 25, 2017. The medical devices regulation initially foresaw a three-year transition period (i.e. implementation by May 25, 2020), but due to the disruptions caused by COVID-19, the EU agreed a one-year extension for implementation by May 2021. The IVD medical devices regulation foresees a five-year transition period (implementation by May 25, 2022). The Europe Office is closely monitoring the implementation of this legislation and considering opportunities to foster regulatory alignment and cooperation initiatives.
- EU’s General Food Law Reform – Earlier in 2019, the EU revised its General Food Law Regulation with the goal of increasing transparency of the EU risk assessment in the food chain, strengthening the reliability, objectivity and independence of the studies used by EFSA, and revisiting the governance of EFSA in order to ensure its long-term sustainability. The new provisions will become applicable on March 27, 2021. In addition, in May 2020, the EC published the Farm-to-Fork Strategy, which lists several proposed future actions covering a range of food and nutrition issues. The Europe Office monitors these and other developments, including to determine potential impacts to FDA engagements.
- Brexit – Since the United Kingdom (UK)’s vote to leave the EU in June 2016, the Europe Office has been closely following Brexit developments and their potential to impact FDA programs and activities and supplies of FDA-regulated products coming into the U.S. from Europe. The UK officially left the European Union on January 31, 2020 following the ratification by both sides of the Withdrawal Agreement and negotiations on the future EU/UK partnership are currently ongoing. Brexit prompted the EMA to relocate from London to Amsterdam and, as a result, the FDA liaison to the EMA also relocated to the new EMA offices in Amsterdam.
- Tobacco Products – By 2021, the EC is set to review the 2014 Tobacco Products DirectiveExternal Link Disclaimer, which lays down rules governing the manufacture, presentation and sale of tobacco and related products. The Europe Office closely monitors the developments in this area and supports the FDA’s Center for Tobacco Products in engagements with the EC and EU-Member State authorities.
Europe Office News
- Equivalence: Using a Trade Mechanism to Ensure Broader Consumer Choice and Open New Markets for Molluscan Shellfish (September 2020)
- Partnering with the European Union and Global Regulators on COVID-19 (June 2020)
- Commissioner Hahn at The German Marshall Fund’s Brussels Forum (June 2020)
- Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators (July 2019)
- International Collaboration on GMP Inspections (December 2019)
- General Principles, Parallel Scientific Advice for Human Medicinal Products (April 2017)
Partnerships and Collaborations
- Partnership with the EMA – FDA recognizes the strong connection between European and U.S. medical product development and, therefore, has built a strong partnership with the EMA. A fulltime FDA liaison to the EMA is embedded in that organization’s Division of International Programs in Amsterdam, while FDA hosts the EMA liaison to FDA as part of the Europe Office’s White Oak staff.
- Staff Exchanges with the EMA – In 2018, FDA hosted four EMA colleagues for one- to two-week intensive “fellowships” in areas including repurposing of medicines, complex generics, regenerative medicine advanced therapies (known as Advanced Therapy Medicinal Products in Europe), and veterinary medicines. EMA, on its part, hosted four FDA colleagues for “fellowships” in scientific advice collaboration in oncology, complex generics, biomarker-based drug development, and risk assessment strategies for facility inspections.
- Parallel Scientific Advice (PSA) for Human Medicinal Products – FDA and EMA have created a mechanism for EMA assessors and FDA reviewers to concurrently exchange their views on scientific issues, with sponsors, during the developmental phase of new medicinal products (i.e., new human drugs and biologics). Sponsors wishing to nominate a product for PSA, follow this link for more information.
- Collaboration with the EFSA – FDA has long partnered with the EFSA on food safety issues, including under a confidentiality commitment signed in 2007. Between 2009 and 2013, FDA and EFSA posted liaison officers within each other’s relevant offices. FDA and EFSA interactions are varied and involve exchanges of information, monitoring of developments on topics related to human and animal food safety, and collaborations in international forums. The Europe Office continues to work to strengthen relations with EFSA and facilitate scientific and technical cooperation in areas of benefit to FDA.
Publications by the Europe Office
- A Saint-Raymond, et al. (2020) “Remdesivir emergency approvals: a comparison of the US, Japanese and EU systems,” Expert Review of Clinical Pharmacology, DOI: 10.1080/17512433.2020.1821650 (https://www.tandfonline.com/doi/full/10.1080/17512433.2020.1821650)
- Kashoki M, et al. A comparison of FDA and EMA decisions for new drug marketing applications 2014-2016: concordance, discordance and why. CPT 2019 Open Access First published 15 July 2019. https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1565?utm_campaign=IU%20Test%20August&utm_medium=email&utm_source=Eloqua
- Are the European Medicines Agency, U.S. Food and Drug Administration, and Other International Regulators Talking to Each Other? CPT 2019. Open Access First published 15 July 2019. https://ascpt.onlinelibrary.wiley.com/doi/pdf/10.1002/cpt.1617
European Institutions and Competent Authorities
- European Union
- European Parliament
- Council of the EU
- European Commission
- European Medicines Agency
- European Food Safety Authority
- European Centre for Disease Prevention and Control (ECDC)
Resources for You
- Contact Information: OGPS Offices
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- FDA Globalization
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