The European Medicines Agency’s Management Board, highlighted new priorities for 2014, which include:
- enhancing cooperation within the European medicines network
- facilitating early stages of medicines development
- improving the quality, integration and accessibility of data held by the Agency
- reinforcing international cooperation to ensure that clinical trials conducted outside the European Union (EU) are of the required high quality
- tackling the issue of antimicrobial resistance and availability of anti-infective treatment options
- improving operational effectiveness and efficiency of the Agency
Forecast and budget
In 2014, the Agency expects a slight general increase in its assessment activities for human medicines compared with 2013. Activities in the early stages of medicines development remain at a high level; these activities, which provide support to sponsors, include scientific advice on clinical development, orphan designation and support to micro-, small- or medium-sized enterprises. A 16% increase in the number of extensions of indication and variations applications is expected. A 12% decrease in the number of initial marketing-authorisation applications received is forecasted, which is mainly due to a lower number of generic applications. The number of applications for new medicines containing a new active substance is expected to be stable.
In the veterinary area, the Agency expects an overall steady level comparable to previous years of the assessment activities, following a high level of applications in 2013. The work programme is accompanied by a budget of €297.2 million, which comprises fee revenue of €236.2 million, an EU contribution of €39.2 million and €20 million for the EMA’s relocation.
Revision of conflicts-of-interests policy
The Board endorsed draft principles that will guide the revision of the Agency’s conflicts-of-interests policy for scientific-committee members and experts. This revision aims at maintaining a pool of high- quality scientific experts while ensuring that experts are free from undue financial or other interests.
Go-ahead for the publication of agendas and minutes of all EMA scientific committees
The Board cleared the way for the publication of the agendas and minutes of the Agency’s Scientific Committees. The minutes of the meetings will be published once they have been adopted. The Agency announced in July 2012 its plan to publish the agendas and minutes of all seven scientific committees before the end of 2013. Similarly, the agenda of the Management Board meetings will now be published ahead of the meeting as of 2014.
Update on next steps towards publication and access to clinical-trial data
Last, but not least, despite all controversy the Board agreed on a set of key principles which will guide the finalisation of the policy on publication and access to clinical-trial data. The policy and an implementation plan will be discussed at the March 2014 Management Board meeting.