EMA publishes 2014 annual report
The annual report published by the European Medicines Agency (EMA) today focuses on the Agency’s key priorities, including the evaluation of medicines and the support to research and development of new and innovative medicines. In 2014, the Agency recommended 102 new medicines for marketing authorisation, both for human (82) and animal (20) use. The number of applications for orphan designationincreased by 63% and requests for scientific advice for human medicines by 16% compared to 2013. Developers of medicines are making more and better use of EMA’s tools aimed at helping patients to get access to effective and safe medicines more quickly.
The capacity for safety monitoring has been strengthened as patients, healthcare professionals and companies followed up on their commitment to report side effects to the Agency. This is reflected in the increase in the number of suspected side effects reported in EudraVigilance, the EU adverse drug reaction collection and management system. For human medicines, the number of side effects reported rose by 6.5% and for veterinary medicines by 27% compared to 2013. A range of new pharmacovigilance activities has become part of the Agency’s core business as a consequence of the implementation of the EU pharmacovigilance legislation. For example, the periodic safety update reports for centrally and nationally authorised medicines that contain the same active substance are now routinely assessed together.
The annual report also highlights some of the main projects, initiatives and achievements in 2014 that had and still have a profound impact on the Agency and the way it operates. Among these are: the adoption of EMA’s policy on thepublication of clinical data which sets a new standard for transparency in public health and pharmaceutical research and development; the launch of a pilot project on adaptive pathways to accelerate access to new medicines for patients; the involvement of patients in the discussions on benefits and risks of medicines assessed by the Committee for Medicinal Products for Human Use (CHMP); the implementation of various new pieces of legislation; and EMA’s move to its new office building.
