EMA Spells Out Plan for Trial Portal and Database
EMA expects a small rise in the pre-authorization activities for human medicines in 2016. Around 546 requests for scientific advice are anticipated, compared to 510 in 2015.
The European Medicines Agency (EMA) has revealed the timeframe for the implementation of the EU clinical trial portal and database.
The Clinical Trials Regulation involves a major overhaul of the processes for authorization and oversight of clinical trials, and is underpinned by a clinical trial portal and database. It will provide a single portal for submission and maintenance of trial applications and authorizations, and support their coordinated assessment and supervision. The portal and database will also serve as the source of public information on the full lifecycle of all clinical trials conducted in the EU, from their initial review up to publication of their results.
The development of the portal and database, which is underway, is guided by the specifications agreed by the EMA Management Board in December 2014. The plan is make available the database and portal for independent audit by August 2017. If the system passes the audit, the EU Clinical Trial Regulation will come into effect by October 2018 at the latest.
EMA expects a small rise in the pre-authorization activities for human medicines in 2016. Around 546 requests for scientific advice are anticipated, compared to 510 in 2015. Among these, EMA expects approximately 33 requests for parallel advice with heath technology assessment bodies. The number of applications for initial marketing authorization in 2016 is expected to remain constant with 110 applications in 2016 versus 112 in 2015.
EMA’s budget for 2016 is forecast to rise by 5.4% to a total of €324.7 million. Its work program for 2016 is to be published on the EMA website in the first quarter of 2016. Sir Kent Woods will step down as Chair of the Board in late December 2015. Vice-Chair, Christa Wirthumer-Hoche, Head of the Austrian Medicines and Medical Devices Agency (AGES), will take the role until the election of a new Chair at the next meeting of the Board on March 17, 2016.
Noël Wathion, EMA Chief Policy Adviser and ad interim Head of EMA’s Stakeholders & Communication Division, has been appointed to follow Andreas Pott in the role as Deputy Executive Director of the EMA. This will be effective from February 1, 2016. Pott is due to retire.
Wathion will be in charge of policy development and preparation for new legislation, emergency/crisis management, liaison with EU institutions, access to documents and proactive publication of clinical data, as well as fostering integration of EMA activities.
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