EMA publishes its work programme for 2014

The European Medicines Agency has published its work programme for 2014.

Legislative developments remain one of the main drivers of the Agency’s priorities this year.

The European pharmacovigilance legislation that became fully operational in July 2012 brought one of the biggest changes to the legal framework for human medicines since the creation of the Agency in 1995, and its implementation is still a significant area of activity for the Agency.

Among the priority activities in this area in 2014 are the further development of methods for collecting best evidence, enhancement of functionalities of EudraVigilance, the European database on adverse drug reactions, the development of a repository for periodic safety update reports (PSURs) as well as a system for monitoring the scientific literature for signal detection.

The Agency will also continue the implementation of the falsified medicines directive that came into force in 2013 and will closely monitor and contribute to the debate on new legislative proposals on the conduct of clinical trials and on veterinary medicines.

This year the Agency will also maintain its emphasis on support to the early stages of medicines development. This is an essential element in the Agency’s contribution to increasing the likelihood of new medicines reaching patients. The Agency’s efforts will focus on promoting the use and integration of existing tools in place to engage in early dialogue with medicines developers, such as parallel scientific advice with health technology assessment bodies or scientific advice in relation to innovative technologies. It will also support the development of new approaches and innovative medicines through the developing specific guidelines.

In 2014, the Agency will continue the work started in 2013 to reorganise its processes and structures in order to better support the work of its scientific committees, to better share knowledge throughout the European medicines regulatory network and to better meet the needs of its various stakeholders. The work will continue to improve the efficiency and effectiveness of the Agency’s operations so that it can continue to effectively conduct its core business activities to the highest level of quality and consistency in a rapidly changing environment.

The European medicines regulatory network is the cornerstone of the Agency’s work and success. In 2014, the Agency will enhance its cooperation with the national competent authorities of the European Union through training, expansion of national experts’ programmes and focusing on IT systems that deliver value to the network. The Agency will also implement a series of measures designed to improve the quality, integration and accessibility of data that it holds for the network and its stakeholders.