Improving the Regulatory Review Process de C. Lumley

Improving the Regulatory Review Process

C. Lumley

S R Walker

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.

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Cuprins

1 International regulatory review times.- 2 What determines speed of review: Need for the product, quality of the dossier or efficiency of regulatory authorities?.- 3 Company strategies to ensure a quick and efficient review: Abiotech company.- 4 Company strategies to ensure a quick and efficient review: A Japanese company.- 5 Company strategies to ensure a quick and efficient review: A transnational company.- 6 Conditional licensing: Advantages and disadvantages.- 7 Dialogue and interaction between regulators and sponsors: Formal, informal or none at all?.- 8 The use of electronic dossiers or CANDAs: Help or hindrance?.- 9 The exchange of assessment reports and training of assessors.- 10 The regulatory assessment report in the new European system.- 11 Industry expert reports: An aid to the reviewer?.- 12 The use of internal and external experts and advisory boards: The European experience.- 13 Highlights of the Pharmaceutical Research and Manufacturers Association proposal for FDA reform.- 14 Suggestions that might be considered for improving the review process.- 15 The ideal future regulatory system: An industry perspective.- 16 What strategies should be considered forimplementation by the end of the century? MHW perspective.- 17 What strategies should be considered for implementation by the end of the century? European perspective.- 18 What strategies should be considered for implementation by the end of the century? CBER vision.- Meeting participants.