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                Office of Global Operations

Office of Global Operations

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          Europe OfficeOffice of Global Operations Europe Office
  
  	
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              Europe Office ImageEstablished in May 2009, the Europe Office serves as the lead for the FDA’s Office of Global Policy and Strategy’s on-site presence in Europe. The Europe Office covers the European Union (EU) 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 the 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 the FDA’s positions in consultation with Centers and Offices;
	Promoting the FDA’s safety and efficacy standards and the advancement of FDA’s international objectives that contribute to improvements in global public health; and
	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 U.S. Mission to the EU
	Amsterdam, The Netherlands, embedded in the European Medicines Agency (EMA), and
	Silver Spring, Maryland at FDA Headquarters in the United StatesContact:

Katherine Serrano, Director
U.S. Mission to the European Union
Regent Boulevard 40 B-1000 Brussels, Belgium

Phone:+32-2-811-5733
BB: +1-240-893-4705
Email: US-FDA-EUR@fda.hhs.gov

**Examples of Europe Office Activities**

**Pharmaceutical Mutual Recognition Agreement (MRA)**

Five years of close collaboration between the FDA, the EU, and the EU member states led to the implementation of the Pharmaceutical Mutual Recognition Agreement or MRA. Under this agreement, the U.S. and the EU may rely on information from inspections of drug manufacturing facilities conducted within each other’s border, freeing up valuable regulatory resources. The FDA also has in place an MRA with the United Kingdom (UK) and we are continuing our collaborations since the country exited the EU as of January 1, 2021. In September 2021, the FDA and United Kingdom announced a Mutual Recognition Agreement for Pharmaceutical Good Manufacturing Practice Inspections of Animal Drugs, a decision to expand the scope of the U.S.-UK MRA to include inspections of animal drugs.

The Europe Office serves a critical role in conducting capability assessments and facilitating other steps necessary to establish and implement MRA processes. This includes conducting an evaluation of the applicable regulatory framework to determine whether the counterpart agency has the capability, capacity, and procedures to carry out routine GMP surveillance inspections that meet FDA requirements. For more information about the MRAs, see the FDA MRA resource page and the FDA Voices blog, “Ensuring Patient Safety and Drug Manufacturing Quality Through Partnership with European Union Regulators.”

**Medical Products**

**Partnership with the European Medicines Agency (EMA)** – Recognizing the strong connection between European and U.S. medical product developers, the FDA has, in turn, built a strong partnership with the EMA, the EU agency in charge of the evaluation and supervision of medicinal products. A full-time FDA liaison to the EMA is embedded in the EMA’s Division of International Programs in Amsterdam, while the FDA hosts the EMA liaison to the FDA as part of the Europe Office. The FDA and the EMA also host fellowships focusing on a range of topics, including complex generics, regenerative medicine, advanced therapies (known as Advanced Therapy Medicinal Products in Europe), biomarker-based drug development, scientific advice regarding oncology and more.

**Parallel Scientific Advice**– Parallel Scientific Advice (PSA) is an FDA-EMA program that provides a mechanism for FDA and EMA experts to concurrently exchange their views on scientific issues with sponsors during the development phase of new medicinal products (i.e., new human drugs and biologics). Sponsors wishing to nominate a product for PSA should follow the FDA-EMA PSA General Principles. For additional information about the PSA process, see the Europe Office’s PSA webinar, FDA-EMA Parallel Scientific Advice (PSA) Program, which was recorded in March 2022. The webinar serves as a tutorial on the PSA program, including how to apply, the best types of candidates, and tips/best practices for future applicants.

**Studying medicines and vaccines in pregnant and breastfeeding populations** – Regulators continue to seek methods and strategies to improve knowledge on the rational use of medicines and vaccines in pregnant and breastfeeding populations, an important subset of women’s health. Regulatory agencies have made strides toward improvement, but much more is needed. Recognizing the importance of international collaboration, the Europe Office actively leads the FDA’s cross-Center efforts with colleagues in Europe and the UK to consider how to address these important public health issues more globally.

**Monitoring and analyzing EU medical products developments** – As the EU implements its new regulations on medical devices and in-vitro diagnostic medical devices, the Europe Office supports the FDA’s Center for Devices and Radiological Health’s engagement with the European Commission and EU member states to promote regulatory cooperation and international alignment.

In the context of the **EU’s** Pharmaceutical Strategy for Europe published in November 2020, the areas FDA is engaging and tracking include shortages and supply chain issues, support for advanced manufacturing and other emerging technologies, data management, and possible adaptations to regulatory processes and tools.

**Foods**

**Partnership with European Food Safety Authority (EFSA)** – EFSA provides independent scientific advice on food-related risks that informs European laws, rules and policymaking. In 2019, the FDA and EFSA agreed to strengthen their scientific collaborations and explore further opportunities for convergence in key areas. See Strengthening Scientific Cooperation Between FDA and the European Food Safety Authority. This commitment led to the establishment of a joint technical working group on the use of Whole Genome Sequencing in food traceability and response to foodborne outbreaks. In addition, EFSA and the FDA have partnered with global regulators to discuss shared challenges and opportunities for effective food safety and risk communication and maintaining consumer trust. The Europe Office continues to work to strengthen relations with EFSA and facilitate scientific and technical cooperation in areas of benefit to the FDA.

**Shellfish Trade** – In September 2020, the FDA concluded its first equivalence determination on shellfish, recognizing 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, as equivalent to comparable U.S. controls. Separately, the European Commission determined that U.S. controls for bivalve molluscan shellfish are equivalent to comparable EU controls. In February 2022, the U.S. and EU concluded negotiations to allow for resumption of bilateral trade in bivalve molluscan shellfish that had been closed since 2011. 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 International Cooperation on Food Safety.

**Monitoring and analyzing EU food safety developments** – 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 to ensure its long-term sustainability. The new provisions became applicable on March 27, 2021.

The Europe Office is monitoring these and other developments to identify and initiate strategic FDA engagements.

**Key links for Food Importers and Exporters**

Information on the FDA Reportable Food Registry for Foreign Governments
	Importing Food Products into the United States
	Exporting Food Products from the United States
	Foreign Food Facility Inspection Program**Cross-cutting and Emerging Areas**

The Europe Office identifies and facilitates early FDA engagement with global regulatory partners in emerging areas spanning a range of FDA-regulated products. The aim is to exchange information, discuss rapidly evolving scientific evidence, and promote convergence in policy formulation, where possible. In consultation with relevant FDA Centers and Offices, we support the FDA’s broader objectives to advance and realize the potential of **digital health technologies**; **technology and data modernization**; and innovation in plant and animal **biotechnology**; as well as combatting **illicit trade** in FDA-regulated products.

The Europe Office is also considering how the EU **General Data Protection Regulation** (679/2016 - GDPR) impacts FDA programs and is monitoring developments related to the European Health Data Space.

Europe Office News

FDA-EMA Parallel Scientific Advice (PSA) Program Webinar (March 2022)
	Global Regulators Envision Paradigm Shift Toward Inclusion of Pregnant and Breastfeeding Women in Clinical Research for Medicines and Vaccines (July 2021)
	Strengthening Scientific Cooperation Between FDA and the European Food Safety Authority (February 2021)
	FDA's New Era of Smarter Food Safety Blueprint: Through a Global Lens (November 2020)
	The Story Behind the Reopening of the Molluscan Shellfish Market(October 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)Publications by the Europe Office

Z Hanaizi, et al. (2022) Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations. Therapeutic Innovation & Regulatory Science. October 2022. https://link.springer.com/epdf/10.1007/s43441-022-00475-0?sharing_token=EY5eMwmzbCHR8pualPMU6Pe4RwlQNchNByi7wbcMAY4JzrSZ0Lr-MNStACpfHpG7O4TgmchNSB_k1ZgfKxB50F0GdELyjhklqYG69-2Wnj9KfIbEC3szXEuRuugUoXoJT_MvAlpNRFuJusc_mvbV6XpiX7I3Ekvm38xTnNF8Ft8=
	J Nooney, et al. (2021) Assuring Access to Safe Medicines in Pregnancy and Breastfeeding. Clinical Pharmacology & Therapeutics. October 2021. https://ascpt.onlinelibrary.wiley.com/doi/10.1002/cpt.2212
	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.1617European Institutions and Competent Authorities

European Union
	European Parliament
	Council of the EU
	European Commission
	Directorate General for Health andFood Safety
		Directorate General for Internal Market, Industry, Entrepreneurship and SMEs
	European Medicines Agency
	European Food Safety Authority
	European Centre for Disease Prevention and Control (ECDC)Resources for You

Contact Information: OGPS Offices
	Countries and Regions Covered by OGPS Offices
	FDA Globalization
	Imports and Exports
	International Arrangements
	News, Speeches, and Publications
	Partnerships and Collaboration
	President's Emergency Plan for AIDS Relief (PEPFAR)

                                                                                  Content current as of:
      10/17/2023Office of Global Operations

          
                        Europe Office
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