Regulatory Focus™ > News Articles > EMA to Engage in Cooperative Activities with European Drug Monitoring Agency

EMA to Engage in Cooperative Activities with European Drug Monitoring Agency

Posted 10 September 2012 | By Alexander Gaffney, RAC 

The European Medicines Agency (EMA) is announcing an enhanced cooperation scheme with the European Monitoring Centre for Drugs and Drug Addiction (EMCDDA) which will see an improved exchange of information on psychoactive medicines or other medicines likely to be abused by some patients and consumers.

The program is a part of the recently implemented EU pharmacovigilance legislation, a portion of which called for EMA and EMCDDA to, "Exchange information that they receive on the abuse of medicinal products, including information related to illicit drugs." The program, announced 7 September 2012, updates an already existing agreement first signed in 2012, EMA officials said.

EMCDDA is similar in theory to the US' Drug Enforcement Administration (DEA), but places a heavy emphasis on its scientific mission and research and does not conduct drug interception activities like the DEA.

The two agencies said they had agreed to "foster cooperation" and cooperate based on four principles: appropriateness, common interest, reciprocity and cooperation. Under an agreement signed by both agencies, EMA will inform EMCDDA about any signals it receives indicating the abuse of regulated medicines. Such information will be transmitted on a confidential basis, EMA said. The two agencies may also exchange information and consult with one another on an ad hoc basis, particularly when resolving the definition of terms contained in risk management plans for particular medicines.

The agreement also stipulates that the two agencies should keep one another informed of each other's activities in areas of mutual interest and coordinate meetings when such interests overlap.

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