EMA–EMCDDA cooperation
EMA Executive Director Thomas Lönngren and EMCDDA Director Wolfgang Götz
The ad hoc cooperation (information exchange) between the EMCDDA and EMA started in 1995 when the two agencies became fully operational. However it was only after the launch of the 1997 EU Joint action concerning the information exchange, risk assessment and the control of new synthetic drugs that the partnership between the two agencies went beyond information exchange to become a fully fledged cooperation. EMA is one of the key partners within the early warning system on new drugs (EWS) and an integral part of the scientific risk assessment of new substances.
The cooperation between the EMCDDA and EMA takes place within the framework of Council Decision 2005/387/JHA on the information exchange, risk assessment and control of new psychoactive substances and the EMA’s initiative on cooperation with other European Union bodies for early identification and management of potential conflicts over scientific opinions. To successfully implement the Council Decision, the EMCDDA and EMA have established a mechanism for bilateral exchange of information on the basis of data available through the EWS, set up by the Decision and the European Union pharmacovigilance system. Electronic tools such as existing databases — EudraVigilance (EMA) and the European Database on New Drugs (EMCDDA) — are being used to allow a rapid and reliable exchange of information. According to the new EU regulation on of 2010 the EMA and the EMCDDA shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs. Formalising the scope and nature of the information exchange on the misuse of substances with medical value (i.e. medicinal products authorised in the Community) is an area of collaboration which is under development.
A new working arrangement between the two agencies was signed in London on 10.06.2010.
