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8 Oct 2012

EMA publishes list of substances monitored by lead member states

A list of EU member states with lead responsibility for monitoring the safety of active substances has been published online by the EMA.

The European Medicines Agency (EMA) has published a list of active pharmaceutical substances for which individual member states will take the lead in monitoring.

Member states will be responsible for monitoring data on certain active substances that are contained in medicines, thereby optimising the use of resources across the EU bloc to protect public health.
For instance, the UK will monitor data on substances such as adenosine and alendronate, while Germany will take the lead on calcium and human albumin solution.

In cases where an active substance has not yet been assigned to an individual member state, all nations will be jointly responsible for monitoring its safety, the EMA confirmed.

The agency said in a statement: "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."

It added that the list will be updated online whenever a lead member state is identified for an active substance.
Experts hope that the work-sharing arrangement will help to identify any new risks associated with individual medicines.

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