Improving the Regulatory Review Process

1. Front Matter

   Pages i-xix

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2. International regulatory review times

   • Neil McAuslane, Stuart Walker

   Pages 1-11

3. What determines the speed of review: Need for the product, quality of the dossier or efficiency of regulatory authorities?

   • David Jefferys

   Pages 13-23

4. Company strategies to ensure a quick and efficient review: A biotech company

   • Ralph Smalling

   Pages 25-32

5. Company strategies to ensure a quick and efficient review: A Japanese company

   • Bram Morgenstern

   Pages 33-40

6. Company strategies to ensure a quick and efficient review: A transnational company

   • Emily Donnelly, James Ritchie, Steven French

   Pages 41-51

7. Conditional licensing: Advantages and disadvantages

   • Maria Holz-Slomczyk, Alfred G. Hildebrandt

   Pages 53-66

8. Dialogue and interaction between regulators and sponsors: Formal, informal or none at all?

   • Dann M. Michols

   Pages 67-74

9. The use of electronic dossiers or CANDAs: Help or hindrance?

   • Roger Williams, David Isom

   Pages 75-82

10. The exchange of assessment reports and training of assessors

    • Andre Broekmans

    Pages 83-88

11. The regulatory assessment report in the new European system

    • Kjell Strandberg

    Pages 89-97

12. Industry expert reports: An aid to the reviewer?

    • Robert Temple

    Pages 99-104

13. The use of internal and external experts and advisory boards: The European experience

    • Gorm Jensen

    Pages 105-109

14. Highlights of the Pharmaceutical Research and Manufacturers Association proposal for FDA reform

    • David R. Savello

    Pages 111-117

15. Suggestions that might be considered for improving the review process

    • Cyndy Lumley

    Pages 119-130

16. The ideal future regulatory system: An industry perspective

    • Eve E. Slater

    Pages 131-138

17. What strategies should be considered for implementation by the end of the century? MHW perspective

    • Kaoru Misawa

    Pages 139-147

18. What strategies should be considered for implementation by the end of the century? European perspective

    • Rolf Bass

    Pages 149-153

19. What strategies should be considered for implementation by the end of the century? CBER vision

    • Kathryn Zoon

    Pages 155-162

20. Back Matter

    Pages 163-171

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Regulatory review is the last major development hurdle that must be passed by a new medicine before it reaches the market. At a time when pharmaceutical companies are reviewing their R&D strategies, and attempting to reduce drug development times, it is extremely important that the review process is made as efficient as possible. The 11th CMR Workshop, held in September 1995, provided the opportunity for regulatory authority and industry personnel from Europe, North America, Australia and Japan to openly discuss views and exchange experiences on the subject of improving the review process. The proceedings of this meeting provide a comprehensive overview of the current review process around the world. The contributors describe the present situation and highlight company strategies and regulatory initiatives to improve the review process. This volume also summarises the suggestions that were developed by the participants, covering many facets of this process, including the quality and size of the dossier, dialogue, submission strategies, feedback and the response to questions.

• assessment
• drug
• drug development
• efficiency
• research

• Centre for Medicines Research, Surrey, UK

  Cyndy Lumley, Stuart R. Walker

Policies and ethics