EMA says its proactive publication of clinical data a success

Just as the European Medicines Agency is preparing for its post Brexit relocation to the Netherlands, and is implementing the next phase of its business continuity plan (BCP) to facilitate the move to Amsterdam, the EMA has published the first report on the implementation of its flagship policy on the publication of clinical data (Policy 0070).

Under this policy citizens, including researchers and academics, can directly access thousands of pages from clinical reports submitted by pharmaceutical companies to EMA in the context of marketing authorization applications for new medicines as of January 1, 2015. Clinical reports give information on the methods used and results of clinical trials conducted to demonstrate the safety and efficacy of medicines.

However, the Agency warns that the relocation will also impact the publication of clinical data as of the second half of 2018 and in 2019. The EMA will liaise with pharmaceutical companies currently preparing their submissions. The Agency will do its utmost to resume this activity to the level outlined at the start of the policy once the relocation is complete.