Europe – Global regulators call for international collaboration to integrate real-world evidence into regulatory decision-making

EMA has endorsed a joint statement calling for international collaboration to enable the generation and use of real-world evidence for regulatory decision-making published today by the International Coalition of Medicines Regulatory Authorities (ICMRA).

The use of real-world data and real-world evidence in the development, authorisation and monitoring of medicines to support regulatory decision-making is rapidly increasing. Although real-world evidence can play an important role in bridging knowledge gaps, there are still challenges that need to be addressed, such as heterogeneous data sources across the globe and different levels of quality of the data. Interested parties also need to deal with various processes for data sharing and access.

During the COVID-19 pandemic, international medicines regulators and researchers have worked together to establish or reinforce collaboration allowing efficient sharing of data and experience in relation to real-world evidence. They agreed to further such collaboration beyond the pandemic…