Many post-authorization studies fail to comply with public disclosure rules
Medical Xpress
February 25, 2026
AI-Generated Deep Dive Summary
A new study highlights a significant issue with post-authorization studies (PAS) registered with the European Medicines Agency (EMA), revealing that many fail to comply with legal requirements to publicly disclose their findings. PAS are conducted after a medicine is approved to gather additional real-world data on its safety and effectiveness. However, the research shows that only 60% of finalized and ongoing studies have uploaded their protocols to the EMA's database, and less than 70% have shared their results. This lack of transparency raises concerns about the integrity of post-marketing surveillance and the public's right to access critical information about drug safety.
The findings underscore a persistent problem in ensuring accountability and openness in the pharmaceutical industry. Post-authorization studies are essential for monitoring the long-term effects of medications and addressing any potential risks that may not have been apparent during clinical trials. When these studies fail to meet disclosure standards, it undermines public trust and limits the ability of healthcare professionals and regulators to make informed decisions based on comprehensive data.
This issue matters deeply to readers interested in health and medical advancements.透明的数据共享是确保药物安全性和有效性的基石。公众和医疗专业人员需要及时获取这些研究的结果，以评估药物的风险和益处，并制定最佳的治疗方案。此外，合规性问题不仅影响患者的安全，还可能削弱监管机构的公信力。因此，提高 PAS 的披露率对于维护公共健康和促进透明度至关重要。
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Originally published on Medical Xpress on 2/25/2026