Regulatory Strategy Considerations for Working with the FDA vs. the EMA

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As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. The Food and Drug Administration (FDA) governs the drug and biologic approval process in the United States, while the European Medicines Agency (EMA) serves the European Union (EU) plus Iceland, Norway, and Liechtenstein. As of January 1, 2021, EU pharmaceutical regulations do not apply to the United Kingdom, which formally left the EU in January 2020.

In this guide, we will explore the regulatory strategy considerations sponsors should bear in mind when working with these agencies, with a focus on the development of drug and biologic products. We will compare the approval processes, formal meetings/scientific advice processes, applications for conducting clinical studies, expedited programs, pediatric plans, and labeling for the FDA and the EMA.