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Office of Global Policy and Strategy 

OGPS STATEMENT

July 8, 2022

FDA Meets with European Food and Drug Regulators

An FDA delegation led by Mark Abdoo, Associate Commissioner for Global Policy and 

Strategy, held a series of meetings with European regulators on July 7-8. 

On July 7, the FDA delegation met with Emer Cooke, executive director of the European 

Medicines Agency, at the EMA’s offices in Amsterdam to discuss their recent 

collaborative successes and consider potential new areas of partnership. Today in 

Brussels, the FDA delegation held separate meetings with food and medical product 

officials from the European Commission’s Directorate-General for Health and Food 

Safety, DG SANTE.

The EMA is an agency of the European Union in charge of the evaluation and 

supervision of medicinal products. DG SANTE is responsible for EU policy on health 

and food safety and for monitoring the implementation of related laws. 

The FDA and the EMA have been sharing information since signing a confidentiality 

arrangement in 2010. This arrangement opened the door for the creation of a series of 

working groups or clusters, which have become the bedrock of FDA and EMA 

engagement. Each of the more than 20 clusters focuses on a special topic or 

therapeutic area that has been identified as requiring an intensified exchange of 

information and collaboration. Cluster participants identify bottom-up technical 

challenges, policy gaps, and real-world examples of public health matters best 

addressed collaboratively. For example, in 2021, a new cluster was formed to further 

efforts to include pregnant and lactating individuals in clinical research.

The long-standing partnership between the FDA and EMA ensured they could work 

together seamlessly during the COVID-19 pandemic. The two agencies addressed a 

broad variety of public health issues involving COVID-19 therapies, vaccines, safety 

monitoring, and drug shortages, FDA officials said. 
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One of the topics that came up today during the meeting with Andrzej Rys, Director of 

DG SANTE Directorate B - Health Systems, Medical Products and Innovation, was the 

Mutual Recognition Agreement (MRA) regarding pharmaceutical inspections. The 

agreement allows FDA and European regulatory agencies to rely on each other’s good 

manufacturing practice inspectional information for human drugs manufacturing 

facilities. Currently, the MRA is being applied to surveillance inspections — including 

those conducted within our respective borders — as well as inspections conducted by 

capable authorities of manufacturing facilities located outside the U.S. and EU. It has 

been instrumental in helping to ensure continued oversight of foreign facilities when 

COVID-related travel restrictions have been in place. 

Over the last two years, the FDA has been able to defer close to 300 inspections in 

Europe by relying on GMP information from inspections conducted by EU partners. In 

the EU, inspections of manufacturing sites are carried out by national competent 

authorities from EU Member States. The EC and the EMA play an important role in 

coordinating these activities in collaboration with the Member States.

Other topics discussed today included potential new areas of cooperation such as illicit 

trade in health products, advanced manufacturing and regulatory science, food outbreak 

response, and nutrition labeling. Koen Van Dyck, DG SANTE’s head of international 

relations unit, led the DG SANTE delegation for talks on food issues.

Following its meeting with DG SANTE, the FDA delegation met for the first time with 

Director-General Pierre Delsaux and staff from the European Health Emergency 

Preparedness and Response Authority or HERA. HERA, a new Directorate General 

within the European Commission, was launched in September 2021 in response to 

preparedness and supply chain issues identified during the COVID-19 pandemic.