European pharmacovigilance network off to a good start

The project to put together a European pharmacovigilance network is off to a good start, but it has not yet been decided how it will be financed, according to a European Medicines Agency (EMEA) executive.

"We will need further reflection," said Noel Wathion, the head of the unit for post-authorisation evaluation of medicines for human use.

The EMEA might take inspiration from the experience of the European Commission's research directorate in network funding, but nothing is definite yet, Wathion said at a meeting of the Organisation for Professionals in Regulatory Affaires.

The project, which has been given the name of ENCePP (European Network of Centres for Pharmacoepidemiology and Pharmacovigilance), will use existing pharmacovigilance and pharmacoepidemiological centres in Europe. Some 50 centres are currently involved, representing 18 countries of the European Economic Area. It is hoped that centres specialising in paediatric medicines will be included in the network.

The next step will be to define the network's structure and discuss the "important points" of financing and conflicts of interest, Wathion continued. The EMEA, which will publish a document on the project's state of advancement on its website after the summer, intends to organise a meeting on the subject in the fourth quarter of 2006.

The pharmacovigilance network project is part of the EMEA Roadmap and the European Risk Management Strategy (ERMS) Action Plan. The Roadmap is a document that sets out the EMEA's strategy until 2010 in order to improve the regulatory environment for medicines in the EU and to stimulate innovation, research and development.

The ERMS Facilitation group includes the Heads of Medicines Agencies group and EMEA members. Its objective is to improve the monitoring of medicines safety in Europe.