European Medicines Agency publishes active substance list with lead Member State responsible for safety monitoring

News 05/10/2012

The European Medicines Agency has published the first File list of active substances contained in authorised medicines for which a lead Member State has been appointed to monitor data in EudraVigilance, in order to validate and confirm signals on behalf of the European Union (EU) regulatory network.

The overall goal of the work-sharing model, whereby one Member State is responsible for monitoring a single active substance contained in a medicine authorised through national, mutual-recognition or decentralised procedures, is to further strengthen the signal detection system in the EU and optimise use of resource across the network for the benefit of public health.

This list of lead Member States monitoring substances in nationally authorised medicines, complements the signal validation work conducted by Agency staff for centrally authorised medicines.

As lead Member States are identified for an active substance the list will be updated online. For those active substances not yet included in the list with a lead Member State, all Member States have joint responsibility for monitoring those medicines they have authorised.

EudraVigilance is a system designed for the reporting of suspected side effects which is managed and coordinated by the Agency on behalf of the Member States.

The Agency and medicines regulatory authorities in Member States are required by legislation to continuously monitor the data available in the EudraVigilance database to determine whether there are new risks or whether risks have changed and whether those risks have an impact on the benefit-risk balance of a medicine.

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