EMEA Reports Progress in Risk-Management Program

London (July 26, 2007)-During a July 10 meeting in Lisbon, the European Medicines Agency (EMEA) and Heads of Medicines Agencies (HMA) reviewed the achievements of the European Risk Management Strategy (ERMS) during 2005–2007 and the program objectives for the next two years. ERMS aims to “provide for a more-coherent approach to the detection, assessment, minimization, and communication of risks of medicines in Europe,” with the goal of strengthening safety monitoring of human-pharmaceutical products in the European Union, according to EMEA.
The organizations announced several areas of progress in ERMS, including the following:

• Implementing the legal tools for monitoring the safety of medicines and for regulatory actions provided for by revised EU pharmaceutical legislation, with particular emphasis on the systematic implementation of risk management plans

• Strengthening the spontaneous reporting scheme through further improvements to implementation of electronic reporting of adverse drug reactions to the “EudraVigilance” database

• Launching the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance project to strengthen the monitoring of medicinal products by facilitating the conduct of multicenter, postauthorization safety studies

• Contributing, in collaboration with the European Commission, to the conduct of research in pharmacovigilance and safety of medicines in the context of the Health Theme of the 7th Framework Programme

• Strengthening the organization and the operation of the EU Pharmacovigilance System.

EMEA and HMA are currently finalizing a work program of activities to further implement ERMS and plan to publish this program after the Nov. 2007 HMA meeting.