Update Clinical Trial Regulation: expected date of application and transparency rules
The Board of the EMA endorsed the addendum to the functional specifications of the EU portal and database, which describes the practical implementation of the transparency rules of the European Clinical Trial Regulation.
According to the Regulation, EMA is responsible for the development and maintenance of a portal and database for the submission of clinical trial applications and authorisations within the EU.
The public will be able to access extensive details of each trial including the major characteristics of the trial, the start and end of recruitment, end date of the trial and substantial modifications to the trial. A summary of results and lay summary will normally be published 12 months after the end of the trial.
The document endorsed by the Board sets out the rules for the publication of this information. It is the outcome of a large public consultation exercise. In addition, EMA also held meetings with different stakeholder groups.
The Board was also updated on the timeline for the implementation of the clinical trial portal and database. The plan is to have the system available for an independent audit by the end of the third quarter of 2016. If the portal and database get a green light from the audit, the Regulation will come into application by the end of 2017. From that point onwards the portal and database will be operational for sponsors and Member States to use for all new clinical trial applications in the EU, and the information from the database will be publicly available.
See for more information the EMA website.