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EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making

On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory decision-making" which briefly describes how RWE, derived from the analysis of RWD, can be useful in the context of regulatory decision-making, the types of studies that can be performed and how EMA can help identify the best resources to address a research question.

Real-world evidence (RWE) is defined as evidence derived from the analysis of real-world data (RWD) to generate insights on the usage and potential benefits or risks of a medicine.

RWE is obtained from sources such as electronic health records, disease registries, health insurance claims data, and data generated from mobile devices and wearables.

RWD can be used to achieve better informed and more efficient regulatory decision-making as a complement to existing evidence. The guidance emphasizes the importance of ensuring the reliability, relevance, and robustness of RWE, as well as the need for transparency and scientific rigor in its use.

Currently, three different pathways are available to answer research questions:

  • The Data Analysis and Real World Interrogation Network (DARWIN EU®)

  • Studies using in-house electronic health databases

  • Studies procured through the EMA framework contracts

Within a few days/weeks, a feasibility assessment can be produced. The amount of time it takes to prepare the study protocol, conduct the analysis, and finalize the report will vary depending on its complexity. It is expected that very simple studies can be carried out within 6-8 weeks, but more complex studies will normally take longer, up to several months in some cases.

Check out this guidance for more information on how will the generated evidence be useful and how will standards be maintained, etc.


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