Improving the Regulatory Review Process: Industry and Regulatory Initiatives (Centre for Medicines Research Workshop)

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. Conditional licensing/use of electronic dossiers/exchange of assessment reports, etc. Front Matter....Pages i-xix International regulatory review times....Pages 1-11 What determines the speed of review: Need for the product, quality of the dossier or efficiency of regulatory authorities?....Pages 13-23 Company strategies to ensure a quick and efficient review: A biotech company....Pages 25-32 Company strategies to ensure a quick and efficient review: A Japanese company....Pages 33-40 Company strategies to ensure a quick and efficient review: A transnational company....Pages 41-51 Conditional licensing: Advantages and disadvantages....Pages 53-66 Dialogue and interaction between regulators and sponsors: Formal, informal or none at all?....Pages 67-74 The use of electronic dossiers or CANDAs: Help or hindrance?....Pages 75-82 The exchange of assessment reports and training of assessors....Pages 83-88 The regulatory assessment report in the new European system....Pages 89-97 Industry expert reports: An aid to the reviewer?....Pages 99-104 The use of internal and external experts and advisory boards: The European experience....Pages 105-109 Highlights of the Pharmaceutical Research and Manufacturers Association proposal for FDA reform....Pages 111-117 Suggestions that might be considered for improving the review process....Pages 119-130 The ideal future regulatory system: An industry perspective....Pages 131-138 What strategies should be considered for implementation by the end of the century? MHW perspective....Pages 139-147 What strategies should be considered for implementation by the end of the century? European perspective....Pages 149-153 What strategies should be considered for implementation by the end of the century? CBER vision....Pages 155-162 Back Matter....Pages 163-171 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