Drug regulators in the European Union have expressed satisfaction with the progress made so far with the European Risk Management Strategy, and have begun to draw up the programme’s priorities for the next two years.

Proposals for the ERMS were agreed in 2002 to detect, assess, minimise and communicate the risks of medicines in the EU. Discussing the Strategy’s progress in Lisbon, Portugal, this month, officials of the European Medicines Agency (EMEA) and the Heads of Medicines Agencies emphasised that no effective medicine comes without risk and that regulation cannot protect the public 100%, but stressed that the ERMS should create a more proactive approach to the safety monitoring of medicines throughout their lifecycle.

Achievements made under the Strategy since 2005 so far to the present


- implementing the legal tools for monitoring the safety of medicines

and for regulatory actions provided for by the revised EU pharmaceutical legislation, with particular emphasis on systematic implementation of risk management plans;

- strengthening the spontaneous reporting scheme through further improving the electronic reporting of adverse drug reactions to the EudraVigilance database;

- launch of the European Network of Centres for Pharmacoepidemiology

and Pharmacovigilance project, which aim to strengthen the

monitoring of medicines through multi-centre, post-authorisation safety studies;

- contributing, in collaboration with the European Commission, to research in the field of pharmacovigilance and the safety of medicines; and

- strengthening the organisation and operation of the EU Pharmacovigilance System.

Science underpins safety monitoring

The EMEA and HMA officials also discussed finalising a further work programme of ERMS activities over the next two years. This will focus on two main areas – improving the operation of the EU Pharmacovigilance System and strengthening the science which underpins the safety monitoring of medicines – and will be impacted by a number of initiatives, including the Commission’s Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance, which is currently being developed with a view to presenting a legal proposal in 2008.

The Commission announced its proposed Strategy in February, after a public consultation revealed problems with the current drug safety monitoring system, including unclear roles and responsibilities, complex reporting rules being implemented differently by the various member states, a lack of robust safety studies and complex decision-making at EU level. The system would be strengthened and clarified, “so that safety issues are rapidly detected and effectively dealt with, based on more robust data,” said Commission Vice-President Gunter Verheugen. "Rationalisation of the EU medicines safety system will free up resources which can then be directed to better protecting the health of EU citizens,” he added.

The HMA plans to publish the new ERMS work programme at its meeting in November.