European Medicines Agency enhances cooperation with EU drug-monitoring agency on psychoactive and abused medicines

News 07/09/2012

The exchange of information on new psychoactive substances and abused medicines has been enhanced today, thanks to an amended PDF icon working arrangement signed in Lisbon by the directors of the European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA).

Today's update to the arrangement, which was first signed in 2010, reflects the new pharmacovigilance legislation, which states that the EMA and the EMCDDA 'shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs'.

The EMA will now inform the EMCDDA of any validated signals of suspected side effects of medicines that are related to drug abuse. A signal is information on a new or known adverse event that is potentially caused by a medicine and that warrants further investigation. A signal is validated once the data have been reviewed and enough evidence found to justify further analysis.

Today's arrangement strengthens the agencies' information-exchange practices and will help them respond in a more timely manner to potential public-health threats.

The EMCDDA is a European Union (EU) agency that exists to provide the EU and its Member States with a factual overview of European drug problems and a solid evidence base to support the drugs debate. The EMA and the EMCDDA have worked closely together since 1997, when they began exchanging information on and assessing the risks of new synthetic drugs in Europe.

Other features of today's arrangement include the exchange of expertise via consultations, projects and meetings and the possibility for the EMA to consult the EMCDDA when defining risk-management plans for selected medicines.

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