At a time when it is becoming usual for medicines to be developed for a
global market and pharmaceutical companies are endeavouring to expedite
the drug development process, Regulatory Authorities are concentrating
on improving their efficiency and effectiveness. Therefore, it is not
surprising that questions are being asked as to how performance might be
measured and compared between different authorities who are now often in
receipt of dossiers that have been submitted to several agencies at the
same time. Issues such as 'what target should be set for the review of
new medicines?' and `how can quality be assured?' are now considered to
be of critical importance.
The twelfth CMR International Workshop, held in January 1997, provided
the opportunity for Regulatory Authority and industry personnel from
Europe, North America, Australia and Japan to openly discuss experiences
and exchange views on how to improve the review process. The proceedings
of this meeting provide a comprehensive overview of the current review
process in different countries and the need for performance measures and
targets. This volume summarises the many suggestions that were debated
at the Workshop, and includes chapters on measuring performance, and on
the integration of quality into the review process.