The European Medicines Agency (EMA) has published its work program for 2014: legislative developments remain one of the priority objectives. European legislation on pharmacovigilance, fully operational since July 2012, has represented one of the biggest changes in the legal framework for medicines for human use since the creation of the Agency in 1995, and will therefore continue to be the focus of attention. Priority activities in this area include further development of methods for gathering better evidence, enhancing the functionalities of EudraVigilance, the European database on adverse drug reactions, developing a repository for periodic safety update reports (Psurs), and implementing a scientific literature monitoring system for reporting reports. The Agency will continue to implement the Falsification of Medicines Directive, and to monitor and contribute to legislative proposals on how to conduct clinical trials and veterinary medicinal products. Support for early-stage drug development will be maintained, as it is seen as essential to help bring new medicines to patients. The work begun last year to reorganize EMA's processes and structures will also continue, in order to better support the work of scientific committees, better share knowledge across the European medicines regulatory network and meet the needs of different stakeholders. The establishment of a European regulatory network for medicinal products is the flagship of the Agency which, also in 2014, will strive to strengthen cooperation with the competent national authorities of the European Union, through training, the expansion of national expert programs and the focus on IT systems. Finally, the Agency intends to implement a series of measures aimed at improving the quality, integration and accessibility of the data it possesses so that they can be used by the network and its stakeholders.
Friday, March 21, 2014 – Pharmacist33
