EMA Sets Out Priorities and Predictions for 2015-2016

Published on: 

Applied Clinical Trials

The Management Board of the European Medicines Agency (EMA) has outlined its priorities for the next two years.


The Management Board of the European Medicines Agency (EMA) has outlined its priorities for the next two years, which include the following:

• Ensure that assessment activities are conducted to the highest standards of quality, regulatory and scientific consistency.

• Facilitate early stages of medicines development in both the human and veterinary areas.

• Enhance cooperation within the European medicines regulatory network, as well as with European and international partners.

• Continue the implementation of pharmacovigilance legislation and clinical trials legislation.

• Provide support to European institutions in the context of the revision of the veterinary medicines legislation.


• Ensure efficient crisis management and responsiveness to public health threats, including addressing antimicrobial resistance and availability of anti-infective treatments.

• Further increase transparency and access to data, and implement stakeholder and communication strategies.

• Improve quality, integration and accessibility of data held by the Agency.

In 2015, EMA expects a general increase in pre-authorization activities in the area of human medicines, particularly a sustained increase in requests for scientific advice on clinical development, including parallel advice with heath technology assessment bodies which aims to facilitate timely access to medicines for patients.

The number of applications for initial marketing authorization is expected to be as high as in 2014 (114 in 2015 versus 118 in 2014). More than 20% of these applications are for medicines for rare diseases (24 in 2015 versus 23 in 2014). The number of applications for medicines containing a new active substance should remain stable.

The budget for 2015 is 302.117 million euros, which represents a 7% increase over 2014 (282.474 million euros). This is mainly due to the overall higher number of applications expected in 2015 and to the application of pharmacovigilance fees.


Read the full release here.