Highlights from the workshop entitled ‘Regulatory Performance: Critical Success Factors in Today’s Environment’, held by the CMR International Institute for Regulatory Science in Washington D.C., 15-16 September 2003
In recent years all regulatory agencies and companies have invested considerable time and resources in major initiatives to improve their review performance, both in terms of efficiency and quality. This activity is ongoing against a background of high profile withdrawals, a decline in the number of new medicines being submitted for marketing authorisation by companies, and a growing perception that the regulatory environment is changing.
The CMR International Institute Workshop was designed to explore the trends and drivers behind these changes and to identify the key elements that are having an impact – positive or negative – on the approval rates of new medicines. A study on ‘The changing regulatory environment: Reality and Perception’ was undertaken among companies and regulatory authorities, in preparation for the workshop, and the outcome is reported separately in R&D Briefing 42.