EMA Endorses Statement on International Collaboration of Real-World Evidence

The European Medicines Agency (EMA) announced on July 22, 2022 that it is endorsing a statement published by the International Coalition of Medicines Regulatory Authorities (ICMRA) calling for the international collaboration in generating and using real-word evidence to make regulatory decisions. The statement was developed after the completion of a workshop organized by EMA, FDA, and Health Canada in June 2022.

Real-world data and evidence are increasingly being used in the development, authorization, and monitoring of drug products, according to EMA, and use of such data can fill knowledge gaps. However, the quality of data, the sources of data, and the processes for sharing data are still challenges.

Regulators have worked together during the COVID-19 pandemic to share data and experience and have agreed to continue to do so after the pandemic. ICMRA members have pledged to “to foster global efforts and further enable the integration of real-world evidence into regulatory decision-making” by harmonizing terminologies, converge real-world data and evidence guidance and best practice, address public health threats, and maintain transparency.

“Global regulators emphasize their commitment to steer the work in these areas which could be taken forward through a variety of existing fora, including the International Conference on Harmonization (ICH), international standardization bodies and clusters of interested regulators,” EMA stated in the press release.

Source: EMA