Role Of Commission In New Eu Drug System

14 November 1994

It is unlikely that there will be anything new in the way of drug regulatory procedures coming out of the European Commission after the European Union's new system for pharmaceuticals comes into effect on January 1, Patrick Deboyser, deputy head of DGIII, E3, at the European Commission in Brussels, told IMS International's annual European Symposium in Brussels last week.

Discussing the Commission's role in the new system in terms of regulatory competence, he said it would maintain its responsibilities for updating EU procedures and implementing legislation. There will also be the task of recasting the EU medicines legislation, merging all directives into a single text (a procedure which is already underway in the veterinary sector). Mr Deboyser estimated that for the human-use medicines sector it will take about a year for the Commission to prepare its proposals for the recasting, and then up to two years for their adoption.

Other areas of responsibility for the Commission will include matters relating to the rational use of medicines and environmental issues such as the use of chlorofluorocarbons. The only new issues on which the Commission can be expected to make legislative proposals are orphan drugs and standards of Good Clinical Practice, he said.

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