Annual report - policy implementation
EMA will publish annual reports listing all products for which clinical data was published in a given calendar year and describing issues experienced in the implementation of the policy. They will also capture any applicant or marketing authorisation holder who has not complied with the policy or has taken legal action.
First report covering 20 October 2016 to 19 October 2017
The report lists the 54 regulatory dossiers published and the corresponding 50 medicines, which include orphan, paediatric, biosimilar and generic medicines.
It also includes the results of the user survey of the clinical data website.