During its 2-day meeting in December, the European Medicines Agency (EMA) Management Board adopted the agency’s work programme and budget for 2015 and a preliminary draft programme for 2016. The priorities for human medicines over the next 2 years include:
• ensuring that assessment activities are conducted to the highest standards of quality and regulatory and scientific consistency
• facilitating the early stages of medicines development
• enhancing cooperation within the European medicines regulatory network, and with European and international partners
• continuing the implementation of pharmacovigilance and clinical trials legislation
• ensuring efficient crisis management and responsiveness to public health threats, including addressing antimicrobial resistance
• further increasing transparency and access to data, and implementing stakeholder and communication strategies
• improving the quality, integration and accessibility of data held by the agency. In 2015 the EMA expects a general increase in pre-authorisation activities for human medicines.
In particular, it anticipates a sustained growth in requests for scientific advice on clinical development, including parallel advice with health technology assessment bodies, in order to facilitate timely access to medicines for patients. The number of applications for initial marketing authorisation is expected to be similar to that in 2014 (114 in 2015 versus 118 in 2014), with more than 20% of applications relating to medicines for rare diseases. The number of applications for medicines containing a new active substance should remain stable.