Future perspectives of regulations — national authorities’ relationship with the EEC
The current multistate procedure for mutual recognition of marketing authorizations by Member States of the EEC does not work well Experience with the concertation procedure, for high technology or biotechnology derived products, is still limited.
New approaches to medicines regulation should be considered in the light of the planned unified market by 1992. Mutual recognition, a concertation procedure and national procedures should be regarded as parallel activities for different kinds of medicinal products, rather than contrasting possibilities.
To improve the effectiveness of these activities, changes will be necessary, particularly within the CPMP. The structure and internal rules of the Committee would require modification to channel expert resources into different working groups for the evaluation of specific drugs and to allow integration with the national regulatory agencies of Member States.
An improvement in the legal situation of the CPMP will only be possible if the Council of Ministers is charged with making the opinions of the CPMP mandatory and operational.
A modified and more efficient CPMP could act as a supranational regulatory body for medicines.
KeywordsMedicinal Product National Authority Marketing Authorization Mutual Recognition Parallel Activity
Unable to display preview. Download preview PDF.