6 luglio 2022 – In the international therapeutic products environment, the use of Real World Evidence (RWE) to support marketing authorisation applications is becoming increasingly important. Experience in recent years has shown that RWE can support the decision-making of regulatory authorities. However, significant challenges remain regarding the quality and interpretation of Real World Data (RWD) to derive RWE, which need to be addressed at the scientific, regulatory and legal levels. According to Swissmedic, there are currently no national or international legal foundations for the inclusion of RWE in the authorisation procedure for therapeutic products. Swiss legislation on therapeutic products requires the results of GCP-compliant clinical trials for the authorisation of medicinal products. The applicable international guidelines, on the other hand, grant RWE a certain status in certain cases. The position paper is intended to provide applicants with initial guidance. Among other things, it sets out the types of application for which Swissmedic currently takes RWE into account and the important aspects that applicants must pay particular attention to.

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