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;
Silver Spring, 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: [1]
Brexit – On June 23, 2016, the United Kingdom (UK) voted to leave the EU. Brexit prompted the EMA to relocate from London to Amsterdam. As a result, the FDA liaison to the EMA also relocated to the new EMA offices in Amsterdam. The Europe Office closely follows 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 Office will also lead bilateral engagements with UK regulatory authorities following Brexit.
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 new general medical devices regulation foresees a three-year transition period (i.e. implementation by May 2020), and the IVD medical devices regulation foresees a five-year transition period (implementation by May 2022). The Europe Office is closely monitoring the implementation of this legislation and considering opportunities to foster regulatory alignment and cooperation initiatives.
Tobacco Products – By 2021, the EC is set to review the 2014 Tobacco Products Directive, 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.
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. The Europe Office is monitoring developments as these revisions are implemented, including to determine potential impacts to FDA engagements.
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
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. url
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. url
(April 2017)