【摘要】 在药品研发、注册、生产、监管、检验核查等过程中，指导原则兼具监管依据和技术要求的双重职能，完善指导原则的全生命周期管理有助于形成科学、公开、透明和社会参与的标准体系。美国FDA指导原则可追溯至1902年，于1997年出台了良好指导原则管理规范(Good Guidance Practice, GGP),从法规层面明确指导原则的性质和效力，规范制(修)订过程。美国FDA在2011和2023年相继发布报告，总结美国FDA和各中心/办公室GGP阶段性实施进展，计划进一步优化形成最佳指导原则制定规范。本研究结合美国FDA已发布指导原则的形成和更新轨迹，分析指导原则启动、起草、审查发布和更新等现状，为我国指导原则全生命周期管理提供可借鉴的思路。更多还原

【Abstract】 In the process of drug research and development, registration, production, supervision, inspection and verification, guidance plays a dual role of regulatory basis and technical requirements. Improving the full lifecycle management of guidance helps to form a scientific, open, transparent, and socially participatory standard system. The guidance of the FDA can be traced back to 1902. FDA introduced the Good Guidance Practice(GGP) in 1997, which clarifies the nature and effectiveness of guidance principles at the regulatory level and standardizes the process of formulation and revision. FDA released reports in 2011 and 2023, summarizing the phased implementation progress of GGP by FDA and various centers/offices, and plans to further optimize and form Best Practices for Guidance. This study combines the formation and update trajectory of FDA-issued guidance to sort out the current situation of FDA’s initiation, drafting, review, release, and update of guidance, providing reference ideas for the full lifecycle management of guidance in China.更多还原