Challenges in Public Disclosure of Post-Authorization Studies
A significant number of post-authorization studies registered with the European Medicines Agency (EMA) do not meet the legal requirements or recommended guidelines for publicly sharing their findings, according to research published in The BMJ. These post-authorization studies, often abbreviated as PAS, are specifically designed to gather additional real-world evidence on the safety profiles and effectiveness of medicines once they have received regulatory approval and entered the market. The investigation reveals that merely six out of every ten completed or still-active post-authorization studies have made their protocols available online, while fewer than seven out of every ten finished studies have submitted their results to the EMA’s dedicated database.
Ensuring that protocols and outcomes from post-authorization studies are accessible to the public plays a crucial role in enabling thorough scientific scrutiny and peer review processes. However, up until now, there has been a notable scarcity of comprehensive data regarding the extent to which studies registered with the EMA actually fulfill these public disclosure obligations.
Methodology of the EMA Data Analysis
In an effort to fill this critical gap, a team of researchers meticulously extracted relevant information from the EMA’s Catalog of real-world data studies during February 2024. Their primary objective was to evaluate the availability of study protocols for both ongoing and completed post-authorization studies, as well as the availability of results specifically for those studies that had reached finalization. The scope of their analysis encompassed all post-authorization studies that had been registered with the EMA starting from November 2010 onward, providing a broad historical perspective on compliance trends over more than a decade.
Under current European Union legislation, there is a clear mandate requiring the protocols and results of category 1 and category 2 studies—those outlined within an EU Risk Management Plan (RMP)—to be uploaded directly to the EMA’s catalog. Beyond these mandatory categories, the EMA extends a strong recommendation for sponsors to upload protocols and results for additional types of post-authorization studies. This includes category 3 studies under the EU RMP, studies that are solely part of non-EU RMPs, and even those post-authorization studies that fall outside any RMP framework entirely.
Detailed Compliance Statistics Across Study Categories
When examining the overall dataset, the researchers found that protocols were publicly accessible for 1,370 out of a total of 2,300 ongoing and finalized post-authorization studies, representing a compliance rate of 59.6 percent. For finalized post-authorization studies specifically, results had been uploaded for 1,014 out of 1,482 studies, equating to 68.4 percent adherence.
Breaking down the protocol availability by specific study categories provides even more granular insights. Among ongoing and finalized studies, protocols were available for 76 out of 112 EU RMP category 1 studies, achieving 68 percent compliance. For EU RMP category 2 studies, 21 out of 33 had protocols uploaded, or 64 percent. In the EU RMP category 3 group, 419 out of 625 studies met the criterion, at 67 percent. Non-EU RMP-only studies showed 87 out of 129 with protocols, also at 67 percent. However, the lowest adherence was observed in post-authorization studies not included in any RMP, where only 715 out of 1,292 studies had protocols available, resulting in a 55.3 percent rate.
Shifting focus to results availability in finalized post-authorization studies, the figures demonstrate higher compliance in legally mandated categories. Specifically, 61 out of 68 EU RMP category 1 studies had results posted, reaching an impressive 90 percent. Similarly, 17 out of 19 category 2 studies complied, also at 90 percent. For category 3 studies, 304 out of 401 uploaded results, or 76 percent. Non-EU RMP-only finalized studies had 56 out of 81 with results, at 69 percent. Once again, studies not part of an RMP lagged behind, with 547 out of 853 providing results, equating to 64 percent compliance.
Key Observations on Adherence and Transparency Issues
The authors of the study emphasize that post-authorization studies registered with the EMA are not sufficiently adhering to either the binding legislation or the advisory recommendations that mandate or encourage the uploading of protocols and results to the Catalog of real-world data studies. They particularly highlight that compliance rates are notably weaker among those post-authorization studies that are not incorporated into an RMP, where disclosure is recommended but not legally enforced. Furthermore, the researchers noted substantial variations in adherence levels depending on the specific sponsors conducting the studies, suggesting inconsistencies in organizational practices and priorities.
Limitations and Considerations of the Research
As with any observational research, this analysis comes with certain acknowledged limitations that warrant careful consideration. For instance, the study captures only a single point-in-time snapshot of compliance status as of the data extraction date in February 2024, which may not fully reflect dynamic changes over time. Additionally, the accuracy and timeliness of the metadata entered for post-authorization studies in the EMA database play a pivotal role in the reliability of these findings, and any delays or errors in data entry could influence the reported rates.
Implications for Research Transparency and Future Actions
Despite these constraints, the researchers assert that evaluating the upload status of protocols and results for EMA-registered post-authorization studies is not only feasible but also serves as a valuable tool for monitoring and scrutinizing compliance with both legal mandates and recommended best practices. They advocate strongly for enhanced adherence across the board to foster greater transparency in medical research. Improved public access to these critical study elements would enable broader scientific review, reduce duplication of efforts, and ultimately contribute to safer and more effective post-market surveillance of pharmaceuticals.
This cross-sectional study, titled “Adherence to legislation and recommendations to publicly post protocols and results of post-authorisation studies registered with European Medicines Agency,” was published in The BMJ in 2026. It underscores the ongoing challenges in achieving full transparency in real-world evidence generation following drug approvals and calls for targeted interventions to address the identified gaps.
