加强新药研发过程,尤其是早期研究阶段的规范化管理,能够将已有新药研发的经验和教训固化下来,从而有效地节约资源、加快新药研发的进程。在某种程度上降低了药物后续开发的风险,并为以后其他新药项目的研发工作提供借鉴。本文着重从研发工作流程和研发管理体系两个方面探讨早期新药研发活动如何进行规范化。 Strengthening the research and development of new drugs, especially the standardized management of early research phases, can solidify the experience and lessons learned from the research and development of new drugs so as to effectively save resources and accelerate the development of new drugs. To a certain extent, reduce the risk of drug follow-up development and provide reference for the research and development of other new drug projects in the future. This article focuses on how to standardize R & D activities of early new drugs from two aspects: research and development workflow and R & D management system.