国际组织推动的药品协同监管信息化举措研究

Research on information-driven initiatives for collaborative medical products administration by international organizations

摘要

目的: 本文研究了国际组织推动开展的药品协同监管信息化举措,以期进一步明晰国际通用监管规则,支持医药产业扩大对外开放合作,进一步助推信息化赋能监管。方法: 通过网站和文献调研,梳理国际药品监管组织在药品标识标准(Identification of Medicinal Products,IDMP)与药品质量知识管理(Pharmaceutical Quality Knowledge Management,PQKM)方面的政策和实践。结果: 研究梳理出药品国际协同信息化监管两大核心举措——IDMP及其应用场景,以及基于IDMP的PQKM体系,并总结了美国和欧盟等的实施进展、国际药品监管机构联盟(International Coalition of Medicines Regulatory Authorities, ICMRA)的试点成效。结论: 提出我国药品监管信息化部门持续关注国际动态、统筹发展和安全等启示与建议。

Abstract

Objective: To summarize the information-based initiatives for collaborative medical products administration promoted by international organizations, with the aim of further clarifying internationally accepted administration rules, supporting the expansion of openness and cooperation in the pharmaceutical industry, and further advancing the empowerment of regulation through information technology. Methods: A combination of website and literature research was used to review the policies and actions of international medical products administration organizations, including the Identification of Medicinal Products (IDMP) and Pharmaceutical Quality Knowledge Management (PQKM). Results: Two core initiatives of international collaborative information-based administration for medical products: the IDMP standard and its application scenarios, and the IDMP-based PQKM system, were identified. The implementation progress in thecountries and regions such as the United States and the European Union was also summarized, as well as the pilot outcomes of the International Coalition of Medicines Regulatory Authorities (ICMRA). Conclusion: The study proposes implications and recommendations for the informationization department of national medical products administration, including continuous attention to international development, coordinated management of development and data security.    

关键词

国际合作 / 监管科学 / 药品协同监管 / 药品标识标准 / 药品质量知识管理

Key words

international cooperation / regulatory science / collaborative pharmaceutical administration / Identification of Medicinal Products / Pharmaceutical Quality Knowledge Management

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