On the international therapeutic product scene, the use of real-world evidence (RWE) to support medicinal product authorisation applications is of growing importance. Experience over the last few years has shown that RWE can assist the regulatory authorities with their decision-making. However, the quality and interpretation of real-world data (RWD) for deriving RWE still pose considerable challenges that need to be addressed at the scientific, regulatory and legal level.
To Swissmedic's knowledge, there is currently no legal basis – either nationally or internationally – for the inclusion of RWE in the authorisation process for therapeutic products. Swiss therapeutic products legislation requires the results of GCP-compliant clinical trials for the authorisation of medicinal products. The applicable international guidelines do, however, attach some importance to RWE in certain cases.
Given the dynamic developments in the use of RWE and the associated regulatory issues, Swissmedic has prepared this position paper to offer some initial pointers to applicants. Among other things, the position paper sets out the types of applications where Swissmedic currently takes account of RWE as well as the key aspects that must be especially heeded by applicants.
Swissmedic actively follows international developments with regard to the regulation and use of RWD/RWE (e.g. the FDA Sentinel System and DARWIN EU) and is in a continuous dialogue with the Access partners and other regulatory authorities with the aim of further evaluating and establishing the value of RWD/RWE in decisions regarding therapeutic agents. Future experience will show whether – and, if so, which – new standards will be required to ensure that the established use of RWE in medicinal product review is harmonised internationally.n.