EMEA reports progress towards ERMS

The London-based European Medicines Agency (EMEA) has issued an update on the facilitation of the European Risk Management Strategy, the purpose of which is to deliver high standards of public health protection for all medicines available on the European Union market. The update pro-vides details of key initiatives across five broad areas which the EMEA and the heads of medicines agencies are work-ing on during the mid-2005 to mid-2007 period.

1) Risk detection: speeding up the implementation of elec-tronic reporting to EudraVigilance in accordance with International Conference on Harmonization standards, including the national competent authorities and the pharmaceutical industry; addressing the need for changes through the newly-established structure of the Eudra-Vigilance Steering Committee and the EudraVigilance Expert Working Group; further developing the Eudra-Vigiliance database by introducing additional functionaries, especially in signal detection and data mining; developing a concept paper on best evidence based on principles outlined in the 2003 ERMS paper; identifying which areas require the development of new methodo-logies via the Innovative Medicines Initiative; publishing a list of medicines requir-ing intensive monitoring; developing a network of acade-mic centers to be involved in intensive drug monitoring; and exploring other methods of risk detection, taking account of initiatives undertaken by regulatory authorities.

2) Risk assessment: with a new mandate, the Pharma-covigilance Working party (PhVWP) covers all products on the EU medicines market; providing a bridge between the PhVWP and the Committee for Human Medicinal Products; strengthening peer-review systems for scientific work; and improving the methodology for risk/benefit analysis through a publicly-consulted concept paper.