| 摘要: |
| 目的 全面理解FDA指导原则管理规范(Good Guidance Practice，GGP)的起草背景、基本结构、主要特点、运行成效及改进方向，为中国将来制定药品监管指导原则管理规范提供参考。方法 采用文献研究与比较法学研究的方法，对美国《联邦公报》等政府文件中与GGP相关的内容作梳理，结合美国行政法律制度分析其生成发展环境。结果 GGP的出台依赖社会力量推动，它一直将指导原则的外延界定、非法律强制性的内涵属性、充分引入公众参与，以及建立通畅的评议反映渠道作为基本内容，而社会共治则是GGP最核心的原则。近些年FDA对指导原则制定过程的科层管理效率也提出了新要求。结论 中国未来可以借鉴GGP在指导原则分类分级、公众参与、部门协作机制等方面的制度成果；同时考虑到中外法律体系差异等因素，还应该在指导原则属性定位等领域进行规范。 |
| 关键词: FDA 指导原则 GGP 管理规范 |
| DOI：10.13748/j.cnki.issn1007-7693.20223073 |
| 分类号:R969.3 |
| 基金项目: |
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| Development and Enlightenment of FDA Good Guidance Practice |
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WANG Bo, SHAO Rong
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Institute of Regulatory Science for Medical Products, China Pharmaceutical University, Nanjing 211198, China
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| Abstract: |
| OBJECTIVE To comprehensive understand the drafting background, basic structure, main features, operational effectiveness and improvement direction of the Good Guidance Practice(GGP), to provide reference for China’s future development of drug regulatory guidelines and management standards. METHODS Studied on the content related to GGP in US Federal Register as well as other government documents, and analyzed its formation and development environment from the US administrative legal system by literature research and comparative jurisprudence. RESULTS The born of the GGP relied on the social forces, the contents always emphasized on the extension definition of guidance documents, the non-legal mandatory attributes, the public participation, and the channels of notices and comments. What’s more, social multi-governance was core principle of the GGP. In recent years, the FDA had also put forward new requirements for the bureaucratic efficiency of formulating guidance documents. CONCLUSION China can learn classification, public participation, bureaucracy cooperation mechanism from the GGP; Considering different legal systems in different countries, it should also integrate the guidance documents into China’s legal constitution. |
| Key words: FDA guidance documents GGP legislation |
