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[药品和医疗器械局(PMDA)关于研发(R&D)战略的药品事务咨询新行动]

[Pharmaceuticals and Medical Devices Agency (PMDA)'s new action for Pharmaceutical Affairs Consultation on Research and Development (R&D) Strategy].

作者信息

Masuyama Koichi

机构信息

Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

出版信息

Yakugaku Zasshi. 2013;133(2):183-6. doi: 10.1248/yakushi.12-00246-1.

Abstract

Universities, research institutions, and venture capitals that possess promising "seed" research or technologies in Japan, are not always familiar with development strategies that lead to commercialization of the products in spite of their excellent science and research. In order to create innovative pharmaceuticals and medical devices originating from Japan, Pharmaceuticals and Medical Devices Agency (PMDA) launched new scientific consultation service, named 'Pharmaceutical Affairs Consultation on R&D Strategy' for universities, research institutions, and venture capitals on July 1, 2011. Through these consultations, the guidance and advice on the tests needed in the early development stage and the necessary clinical trials would be provided toward commercialization.

摘要

在日本,拥有前景广阔的“种子”研究或技术的大学、研究机构和风险投资公司,尽管其科研水平卓越,但并不总是熟悉将产品商业化的发展战略。为了创造源自日本的创新药品和医疗器械,药品和医疗器械局(PMDA)于2011年7月1日为大学、研究机构和风险投资公司推出了一项新的科学咨询服务,名为“研发战略药品事务咨询”。通过这些咨询,将为产品商业化提供早期开发阶段所需测试以及必要临床试验方面的指导和建议。

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