Policy on Publication of clinical data

In a report published on 16 July regarding the implementation of its flagship policy on the publication of clinical data (Policy 0070), the EMA has announced that Brexit and the Agency’s relocation will result in some areas of work being “temporarily reprioritised, suspended or postponed to resource Brexit preparedness activities and safeguard core activities”. The Agency has explained that this will mean a reduced publication of clinical data during the second half of 2018 and in 2019. However, it notes that this reduction is only temporary and its “proactive publication level” will be restored to the level set out at the start of the policy once the relocation is completed.

This follows its previous announcement, on 27 June 2018, explaining that the Agency is no longer in a position to process access to documents requests issued from outside the EU.

The report also sheds light on the total number of documents published on the Clinical Data Publication (CDP) website, the amount of commercially confidential information (CCI) redacted, the reasons for rejecting redactions and the anonymisation techniques used by the Agency.

The report indicates that the EMA accepted 24% of CCI redactions proposed by pharmaceutical companies, with the overall result that only 0.01% of 1.3 million pages (3,000 documents) published contained CCI redactions. The most common reasons for rejecting redactions were insufficient justification and information already existing in the public domain. The key reasons for accepting redactions were the provision of detailed information on analytical assays or methods and justifications based on future development plans.