Global drug regulators to embrace real-world evidence

The European Medicines Agency (EMA) has backed a joint statement by global regulators calling for greater collaboration on the use of real-world evidence in regulatory decision-making.

The potential for taping into real-world data to inform how new medicines are developed, approved and monitored has been rising up the agenda for more than a decade. However, regulatory authorities have been reluctant to embrace a field where the quality of data can vary. The EMA says challenges remain, particularly when it comes to collecting and using real-world evidence from a variety of global sources.

During the COVID-19 pandemic, medicines regulators and researchers worked together to establish or reinforce collaboration allowing efficient sharing of data and experience in relation to real-world evidence. Now, in a statement issued under the International Coalition of Medicines Regulatory Authorities, it seems leading medicines decision-makers plan to step up their collaboration in this area.

The ICMRA, which includes the EMA, the US FDA and Health Canada, pledges to further enable the integration of real-world evidence into regulatory decision-making. Regulators have committed to greater harmonisation of terminologies and common approaches to developing guidance for industry and others.