The EMA has announced the decision of its management board to resume its proactive clinical data publication policy after a four year-long pause. The application of the proactive publication policy will follow a staggered approach where priority will be given to data relating to new marketing authorization applications that involve new active substances.
A decision to suspend publication of clinical data was made in December 2018 to support EMA's operational continuity during re-location of its headquarters from London to Amsterdam following the UK's withdrawal from the European Union. Clinical data relating to treatments and vaccines for COVID-19, however, continued to be published during this time on an exceptional basis to meet public demand for publication of information, facilitate global research and enhance trust in related regulatory decisions across the EU.
The policy first came into effect on 1 January 2015 and applies to medicines submitted for evaluation in accordance with the centralized procedure established in Regulation (EC) No 726/2004 ("EMA Regulation") after this date. It also covers clinical reports for applications submitted after 1 July 2015 to vary a marketing authorization for an extension of a therapeutic indication. The proactive publication policy requires EMA to provide public access to extensive information included in clinical trial reports and individual patient data submitted to the EMA by medicinal product manufacturers in support of their marketing authorization applications. The information is published following the European Commission's decision on the grant of a marketing authorization or, in case an application for marketing authorization is withdrawn, before a related EMA opinion has been adopted.
The rationale underpinning this policy is to enable transparency in relation to information on medicinal products in accordance with Article 80 of the EMA Regulation. According to EMA, this policy aims to:
- facilitate the application of new knowledge to future research by the scientific community;
- avoid duplication of clinical trials, foster innovation and encourage development of new medicines;
- allow the scientific community to re-assess clinical data; and
- allow the public to scrutinize regulatory decision making, thus building public trust and confidence in EMA's scientific and decision making processes.
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