RWD/RWE In 2023: Regulatory Policy World Tour

By Elena Popa, Max Wegner, Patrick Brady, Vada Perkins, Shefali Goyal, and Ulrike Bodesheim, Bayer AG

The rapid progress and deployment of COVID-19 vaccines owe their success to the invaluable contributions of real-world data and evidence (RWD/RWE). However, the pursuit of utilizing, comprehending, and embracing RWD/RWE in the pharmaceutical development process has long been ongoing.

While regulatory bodies like the U.S. FDA, EMA, and Taiwan FDA (TFDA) have adopted a more practical approach in formulating guidelines, regulations, and frameworks in recent years, it is crucial that the life sciences industry establish harmonized international collaboration and regulatory standards that adhere to similar scientific principles, if not identical ones.

With that goal in mind, there is still much work to be done in terms of enhancing predictability, collecting and interpreting data, refining methodologies, and obtaining acceptance from regulators, HTAs, and payers. In 2023, many anticipate the ICH Assembly’s take on the Reflection Paper drafted by FDA, EMA, and Health Canada, focusing on “international harmonization of real-world evidence terminology, and convergence of general principles regarding planning and reporting of studies using real-world data, with a focus on effectiveness of medicines.”

Learn more about what the industry considers to be priorities for the year, as well as RWD/RWE focuses within each region around the globe.