Regulators commit to collaborating on RWE integration

Both the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have endorsed a statement calling for international collaboration on integrating real-world evidence (RWE) into regulatory decision-making.

The statement, published by the International Coalition of Medicines Regulatory Authorities (ICMRA), describes how collaboration between regulators and researchers that formed a critical aspect of the world’s COVID-19 response could be leveraged to enhance medicines regulation beyond the pandemic.

The use of real-world data (RWD) and RWE in the development, authorisation and monitoring of medicines to support regulatory decision-making is rapidly increasing. Although RWE 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.

In their statement, ICMRA members pledge to foster global efforts and further enable the integration of RWE into regulatory decision-making. They identify four focus areas for regulatory cooperation:

• harmonisation of terminologies for RWD and RWE
• regulatory convergence on RWD and RWE guidance and best practice, including establishing suitable scenarios where RWE may contribute to regulatory decision-making
• readiness to address public health challenges and emerging health threats, and
• transparency – define common principles for the systematic registration of study protocols and results, as well as promoting publication of study results in open-source, peer-reviewed journals.

Global regulators emphasise 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 standardisation bodies and clusters of interested regulators.

The joint statement was developed following an ICMRA workshop on real-world evidence co-organised by EMA, US FDA and Health Canada, held in Amsterdam in June 2022. Participants from more than 40 countries, representing medicines regulatory authorities globally as well as representatives from the World Health Organization (WHO), shared their accomplishments and challenges in generating RWE to support the evaluation of medicines. As a next step, international medicines regulators will discuss concrete actions to implement the above-mentioned four areas of collaboration.