EMA Sets Budget and Priorities for 2014, Promotes Transparency

In a bid to improve transparency in 2014, the European Medical Agency’s December Management Board Meeting cleared the way for the publication of the agendas and minutes of the Agency’s Committee for Medicinal Products for Human Use (CHMP), Committee for Medicinal Products for Veterinary Use (CVMP) and Committee for Advanced Therapies (CAT). This week the EMA will publish for the first time the agendas of the December meetings of these three committees. It will then become standard practice to publish all Committees’ agendas at the start of the meetings.

In agreeing its work program and €297.2 million budget for 2014, the Board predicted that next year will see “a slight general increase in its assessment activities for human medicines compared with 2013.” A 12% decrease in the number of initial marketing-authorization applications received is forecast, 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. Activities in the early stages of medicines development, however, remain at a high level, and a 16% increase in the number of extensions of indications and variations applications is expected.

Further EMA priorities for 2014 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 with emphasis on inspection cooperation and capability building;

• tackling the issue of antimicrobial resistance and availability of anti-infective treatment options; and

• improving operational effectiveness and efficiency of the Agency.