European Medicines Agency (EMA)

EMA–EMCDDA cooperation

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. An updated working arrangement between the two agencies was signed in Lisbon on 7 September 2012.

On 7 December 2018, the EMCDDA and EMA signed an updated working arrangement. The former (2012) arrangement, which enabled the bilateral sharing of information through the pharmacovigilance system, largely on new psychoactive substances (NPS), was extended to include the abuse of substances intended for medicinal use in humans or veterinary products. This reflects the dynamics of the European drug market and the adulteration of existing drugs with medicinal products.