我国生物药产业标准体系构建研究

摘要：

【目的】为构建较全面、系统、协调和先进的国家生物药产业标准体系，并提出基于标准化视角的对策建议。【方法】运用综合标准化法和系统工程法相结合的方法，构建我国生物药产业标准体系；运用标准工程学方法，分析我国现行生物药标准的供给主体、市场主导标准供给和产业链标准结构布局。【结果】我国虽已初步建立较完善的生物药标准体系，但仍存在标准体系不完善、生物药产业标准供给模式不合理、产业链上中下游标准分布不均衡等问题。【结论】应持续完善标准体系，优化标准供给模式，强化标准实施效益分析，积极参与国际标准化组织治理，为持续完善我国生物药产业标准体系提供标准化技术支撑。

Abstract:

[Objective] The study aim to build a more comprehensive, systematic, coordinated and advanced biological industry standards system in China, and put forward countermeasures and suggestions based on the perspective of standardization. [Methods] The standards system of biopharmaceutical industry in China is constructed by combining the comprehensive standardization method and the system engineering method. The standard engineering method is used to analyze the supply subject, market-led standard supply and industrial chain standard structure layout of China’s current biopharmaceutical standards. [Results] Although China has initially established a relatively complete biopharmaceutical standards system, there are still some problems, such as imperfect standards system, unreasonable standard supply mode of biopharmaceutical industry, and unbalanced distribution of standards in the upper, middle and lower reaches of the industrial chain. [Conclusion] It is necessary to continuously improve the standards system, optimize the standard supply mode, strengthen the benefit analysis of standard implementation, actively participate in the governance of international standardization organizations, and provide standardized technical support for the continuous standard system of China’s biopharmaceutical industry.

引用格式：樊哲，汤梓斌，李山，等.我国生物药产业标准体系构建研究 [J]. 标准科学，2026（3）：104-111.

基金项目：本文受广东省自然科学基金面上项目“基于案例推理的养老服务风险评估关键技术与风险防控规范化”（项目编号：2020A1515010689）资助。

作者简介：樊哲，本科，高级工程师，研究方向为安全管理、标准化与技术性贸易措施。汤梓斌，硕士，知识产权师，研究方向为专利导航、专利标准化、数据可视化分析。李山，本科，工程师，研究方向为标准化与技术性贸易措施。叶美君，硕士，经济师，研究方向为专利与标准融合、知识产权转化运用。臧兴杰，通信作者，硕士，高级工程师，研究方向为标准化与技术性贸易措施。罗湘建，硕士，助理工程师，研究方向为专利导航、专利标准化。