试谈药物研发与政府管理政策

Drug development and government policy

本文通过分析不同时期与药物研发密切相关的科技管理政策与药品审批、知识产权等制度的演变过程,认为新药研发的发展离不开国家政策的引导和支持。同时提出新时期下,国家级科研院所开展创新药物研发过程中需要关注以下几方面的问题:新药研发项目的确立应当围绕国家需求和临床需求,应重视对治疗某些重大疾病新的作用机制与新靶点的理论探索,应充分利用国家的特殊政策和支撑条件以加快研发速度,研发过程中需要一个高水平的研发核心小组负责综合分析,统筹安排,同时根据国内外情况变化与研发的进展,适时申请专利、科研计划项目以及新药注册,争取开发出具有国际竞争力的创新药物。

The author analyzed the changes in different periods of science and technology, management, administration of drug approval and intellectual property; then concluded that the new drug development in China can not be separated from national policy guidance and support. In the future, the national drug development insti tutions should pay attention to following issues when researching and developing a new drug. The new drug develop ment project should be met the requirement of the country and the clinical therapy. The national drug development institutions should pay more attention to the new mechanism and new target for the treatment of some important dis ease, and should fully use the national policy and nationally supported hardware to accelerate the new drug develop ment process. In the development process, a senior expert group is necessary to comprehensively analyze the results and control the progress of the project. In the meantime, it should be determined when to apply the patent, national research project and new drug registration according to the changing situation of the in/outof the country and the progress of the project, in order to develop an international competitive new drug.