Transparency of post-authorisation studies

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Source: BMJ

Original: http://www.bmj.com/content/392/bmj.s371.short?rss=1...

Published: 2026-02-26T03:47:26-08:00

Transparency in health care research is a long-standing priority that has led to an assessment of the transparency of clinical trials and observational studies.[1] The European Medicines Agency (EMA) has required since 2012 that all post-registration studies classified as a risk minimization plan (RMP) category 1 or 2 have their protocol and results published in a public repository, which will migrate to the EMA real-world data catalog in 2024.[1] Category 1 RMP post-authorisation studies are those imposed by the EMA as a condition for the granting of a marketing authorization and to be carried out after the granting of that authorisation.[1] These requirements also apply in cases where marketing authorization is granted under exceptional circumstances.[1] Repositories such as the EU Post-Authorisation Register (PAS) contain metadata of observational research studies and information on their transparency.[1]