Improving the Regulatory Review Process: Assessing Performance and Setting Targets

1. Front Matter

   Pages i-xix

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2. Assessing performance and setting targets

   • Terry Eaves

   Pages 1-12

3. Current regulatory reforms and improvements in the review process

   • Fernand Sauer

   Pages 13-19

4. Current regulatory reforms: CBER

   • Kathryn Zoon

   Pages 21-28

5. Improving the review process: The view of the Japanese MHW

   • Yoshinobu Hirayama

   Pages 29-40

6. Comparing the performance of the Canadian TPD with other regulatory authorities

   • Beth Pieterson

   Pages 41-48

7. Measuring performance: The view of the TGA

   • John McEwen

   Pages 49-59

8. Why have targets for the review process? The view of the EMEA

   • Rolf Bass

   Pages 61-71

9. Why have targets for the review process? An individual viewpoint

   • Emily Donnelly

   Pages 73-85

10. Key milestones in the regulatory review process

    • Kate Thomas

    Pages 87-113

11. How do you measure the quality of the scientific assessment and the review process? The view of the MCA

    • David Jefferys

    Pages 115-123

12. Ensuring the quality of the scientific assessment and the review process: The FDA’s good review practice initiative

    • Murray Lumpkin

    Pages 125-133

13. Outcome of syndicate discussions

    • Neil McAuslane, Stuart Walker

    Pages 135-150

14. Back Matter

    Pages 151-163

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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.

• assessment
• drug
• drug development
• efficiency
• research

• Centre for Medicines Research International, Carshalton, Surrey, UK

  Neil McAuslane, Stuart Walker

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