Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency: cross sectional study.

ABSTRACT:

Objective

To assess whether post-authorisation studies registered with the European Medicines Agency (EMA) adhere to legislation and recommendations to publicly post study protocols and results.

Design

Cross sectional study.

Setting

Data extracted from the EMA Catalogue of real-world data studies in February 2024, including post-authorisation studies registered since November 2010. EU legislation requires EU risk management plan (RMP) category 1 and 2 studies to upload the protocol and results to the catalogue. The EMA also recommends uploading the protocol and results for all other registered post-authorisation studies, including EU RMP category 3 studies, non-EU RMP-only studies, and those not included in an RMP.

Included studies

2300 (1484 finalised; 816 ong

SUBMITTER: Ramezani P 

PROVIDER: S-EPMC12934507 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature