It has been over a year since the EMA implemented Policy 0070 on the Publication of Clinical Trial Data; the EMA have published a guidance document and a report of the first year since it was launched (Oct 2016-Oct 2017).
Under Policy 70, clinical data has now been published for over 50 products, which can be freely accessed by the General Public. The EMA is the first Medicines Regulatory Authority to provide such open access to the data submitted in support of Marketing Authorisation Applications, demonstrating its commitment to the principle of transparency.
The report showed that the data had been viewed on 22, 144 occasions by 3, 641 users. The clinical data website can be accessed by log-in to an EMA account. Documents can be downloaded for printing if required.
A User Survey showed that the majority of users found the website easy-to-use and found the published data useful, although frustration was also expressed with the absence of individual line listings, which the EMA is due to address in the next stages of the project.
Details are provided on anonymization of data and redaction of commercially sensitive information, for which guidance is provided for Stakeholders.
EUDRAC is currently involved in the preparation and submission of clinical data onto the EMA data website for its clients. Please contact us if you have any questions about these requirements.