Examining the Impact of Real-World Evidence in EMA Regulatory Decisions

Real-world data (RWD) and the real-world evidence (RWE) generated from it are increasingly used in health technology assessment (HTA) decisions from regulatory bodies worldwide, including the European Medicines Agency (EMA). In an open-access article published in Clinical Pharmacology  & Therapeutics, learn more about how the EMA uses RWE in its decision-making.

According to the authors, “RWE plays an increasing role in regulatory decisions for products for which randomized controlled trials are deemed unethical or unfeasible, such as medicines for very rare diseases or for “precision medicines.” The results may serve as a basis for future guidance for applicants and regulators in the use of RWE in medicines development.”

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(Source: Clinical Pharmacology & Therapeutics, October 17^th, 2023)