Future perspectives of regulations — the concept of a European medicines office
The current, diverse, systems used for reviewing applications for product licences by national authorities within the Member States of the European Community are inappropriate to deal with medicines regulation in the future.
Total mutual recognition is unlikely to be successful and the experience to date on mutual recognition through the CPMP multi-state procedure is not encouraging.
A European Medicines Office should be created consisting of a professional secretariat with advisory bodies and procedures for the timely review of applications and appeals.
National authorities within each Member State would still have a role in medicines regulation.
KeywordsMember State Medicine Regulation National Authority Marketing Authorization Mutual Recognition
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