| 曹萌,丁力承,胡延臣,王亚敏,李香玉.药品连续制造全球监管发展现状与思考[J].中国药事,2022,36(4):364-376 |
| 药品连续制造全球监管发展现状与思考 |
| Current Situation and Considerations on Global Regualtions for Continuous Pharmaceutical Manufacturing |
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| DOI：10.16153/j.1002-7777.2022.04.001 |
| 中文关键词: 药品 连续制造 指南 监管 发展现状 |
| 英文关键词: drugs continuous manufacturing guidelines regulation current situation |
| 基金项目:国家重点研发计划《PAT相关的药品监管法规草案和实施指南》(编号 2017YFF0210100) |
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| 中文摘要: |
| 目的：在连续制造技术越来越多地应用在药品领域这一背景下，综述相关法规指南从概念探索、 正式发起至发布的发展历程，介绍全球多个采用连续制造技术生产药品获批上市的概况，探讨促进我国业界和监管机构借鉴全球药品连续制造发展经验。方法：通过对比传统的批量制造技术以分析连续制造具有的优势和面临的挑战，结合对全球监管指南制定过程中各监管机构对策的梳理，研究相关共识的发展考量和意义。结果：药品连续制造监管发展已经进入了新的时代，我国相关法规指南的制定和产业技术水平提升需要借鉴全球发展的经验，特别是国际人用药品注册技术协调会及美、欧、日等国家药品监督管理机构或国际组织的现有指南在批定义、工艺验证、稳定性等方面的监管对策，为该新兴技术的监管科学研究提供理论基础。结论：通过对药品连续制造全球监管发展现状的综述和思考，为我国相关法规、技术指南和标准的制定提供参考，并希望为产业发展发挥促进作用。 |
| 英文摘要: |
| Objective: To review the development process of the guidelines for relevant laws and regulations from the following aspects: exploration of the concept and the official launch and release of the idea, to introduce the general situation of those drugs approved for marketing,which were produced by continuous manufacturing technology and to discuss how to promote China's pharmaceutical industry and regulatory authorities to learn from the development experience of global continuous manufacturing under the circumstances that continuous manufacturing technology has been applied in pharmaceutical industry with a growing trend. Methods: The advantages and challenges of continuous pharmaceutical manufacturing technology were analyzed by comparing it with traditional batch manufacturing technology, and the development considerations for relevant consensus and the significance were studied by combing the countermeasures of various regulatory agencies in the process of formulating global regulatory guidelines. Results: Since the global regulation of continuous pharmaceutical manufacturing has entered a new era, the formulation of relevant regulatory guidelines and the improvement of industrial technology in China need to draw on global development experience, especially we need to learn from the regulatory countermeasures in batch definition, process validation and stability in the existing guidelines of ICH, national drug regulatory agencies of US, European countries, Japan and other international organizations so as to lay a theoretical basis for the regulatory scientific research on this emerging technology. Conclusion: The reviews and considerations for the current situation of the global regulatory development of continuous pharmaceutical manufacturing will provide references for the formulation of relevant regulations, technical guidelines and standards in China and will promote the development of the industry. |
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