The role of real-world data (RWD) and real-world evidence (RWE) in supporting the development of medicines across their different stages of development and use is evolving rapidly. However, challenges exist, due for example to heterogeneous data sources, different levels of data quality, and various governance models for data sharing and access. Close collaboration between regulators across the world can help address these challenges. ICMRA can play an important role by catalysing increased cooperation on the use of RWE for regulatory decision-making.
The timely work undertaken by regulators and researchers to address the unprecedented challenge of the COVID-19 pandemic, as well as lessons learnt throughout the last two years, have led regulators to establish or reinforce collaborations allowing efficient sharing of data and experience. These collaborations can be further leveraged to medicines regulation beyond the pandemic. In June 2022, EMA, FDA, and HC co-chaired an ICMRA workshop (programme in Annex) to share experience on accomplishments and challenges of RWE in medicines regulation, and to identify opportunities for future regulatory collaboration.
Opportunities for collaboration
The June 2022 ICMRA workshop on RWE identified four areas of opportunities for regulatory collaboration which could help address common challenges and further enable the integration of RWE into regulatory decision-making. They are:
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