| 曹辉,丁力承,胡延臣,王亚敏,李香玉.国外已上市连续制造药品的注册审评情况及其启示[J].中国药事,2022,36(4):377-383 |
| 国外已上市连续制造药品的注册审评情况及其启示 |
| On Registration Review of Continuous Manufacturing Drugs in Foreign Markets and Its Implications |
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| DOI：10.16153/j.1002-7777.2022.04.002 |
| 中文关键词: 药品 连续制造 注册审评 监管 |
| 英文关键词: drugs continuous manufacturing registration evaluation regulation |
| 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：借鉴国外已上市连续制造药品的注册审评要点，为我国推进药品连续制造相关监管法规、 技术指南和标准制定等方面提供参考。方法：调查研究全球已上市口服固体制剂连续制造产品在注册过程中的工艺评估及审评情况，结合案例分析和连续制造相关的法规要求，梳理连续工艺产品在注册和审评过程中的关注点。结果与结论：药品连续制造在国外已经有较为成功的应用，监管部门应重视与业界早期沟通，并在审评阶段重点关注批量的定义、工艺验证、技术转移等研究资料。随着ICH Q13的落地实施，建议我国借鉴国外已上市连续制造药品的工艺评估情况并结合相关法规要求，制定符合国情的注册审评指南。 |
| 英文摘要: |
| Objective: The key points of registration review of the continuous manufacturing drugs in foreign markets were borrowed and used so as to provide references for the formations of the relevant regulations, technical guidelines and standards related to the continuous manufacturing of drugs in China. Methods: The technological evaluation and reviews of the globally-listed continuous manufacturing oral solid products (OSD) during the registration process were investigated and studied and the key points of the continuous manufacturing products in the process of registration and review were summarized by analyzing cases and the regulations related to continuous manufacturing. Resultsand Conclusion: Continuous pharmaceutical manufacturing has been successfully used in foreign countries. Regulatory authorities should attach importance to early communication with the industries, and pay special attention to such research materials as batch definition, process validation, technology transfer,etc. in the review stage. With the implementation of ICH Q13, it is recommended that China learn from the process evaluation of the listed continuous manufacturing drugs in foreign countries and formulate the guiding principles of registration review in line with the national conditions. |
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