EMCDDA and EMA step up cooperation

EU drugs and medicines agencies sign agreement today in London

Exchanging information on new psychoactive substances and misused medicines is facilitated today, thanks to a new working arrangement signed in London this afternoon by the European Medicines Agency (EMA) and the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) (1).

The signatories were EMA Executive Director, Thomas Lönngren and EMCDDA Director Wolfgang Götz.

The two EU agencies have worked closely together since 1997 when they began exchanging information on, and assessing the risks of, new synthetic drugs in Europe (2). Since 2005, they have cooperated in implementing the three-step legal instrument through which Europe now monitors and acts on new psychoactive substances (3). Where relevant, the bodies exchange data from the EU early-warning system on new psychoactive substances and the EU pharmacovigilance system, which monitors the safety of medicines (4).

The new working arrangement furthers cooperation and boosts information exchange between the agencies.  The EMCDDA reports on an ad hoc basis to the EMA on any misuse of medicinal products detected through its networks (complementing information gathered through the EU pharmacovigilance system). The new arrangement opens doors for the EMA to provide ad hoc reports to the EMCDDA on the misuse of authorised medicinal products. 

In addition to increased reporting, the document allows for greater exchange of expertise between the two agencies (e.g. via consultations, projects and meetings), while ensuring the optimal use of resources. The document also states that any conflict of scientific opinion relating to the risk assessment of a given substance should ‘be resolved at an early stage’. Among the new features of the arrangement is the possibility for the EMA to consult the EMCDDA when defining risk management plans for selected medicinal products.

The EMCDDA and the EMA are currently collaborating in an ongoing European investigation into the health and social risks of the new psychoactive substance, mephedrone. The EMA will take part in the risk assessment of the drug on 15 July, under the auspices of the EMCDDA Scientific Committee (5).

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