| 李璇,陈佩毅,王爽,王晓英,黎依娴,张一凡,毕军,江映珠.药品技术转移变更研究中存在问题分析[J].中国药事,2020,34(8):882-890 |
| 药品技术转移变更研究中存在问题分析 |
| Discussions on Existing Problems in the Change Research of Drug Technology Transfer |
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| DOI：10.16153/j.1002-7777.2020.08.005 |
| 中文关键词: 药品 技术转移 申报资料 补正资料意见 |
| 英文关键词: drug technology transfer application materials requirements of supplementary information |
| 基金项目:广东省食品药品监督管理局科技创新项目(编号GDFDA KJ01-2018) |
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| 中文摘要: |
| 目的：为拟开展技术转移变更研究的申请人提供参考和建议。方法：收集广东省药品审评认证中心对药品技术转让申请发出的补充资料通知，结合资料分类和品种类别对补正资料意见进行统计分析。 结果：对59份补充资料通知中的257条补正资料意见进行归纳分析，其中条数占比最高的前5项为质量标准及分析方法验证(23.7%)、质量对比研究(19.5%)、生产工艺和过程控制(12.8%)、物料控制 (10.5%)、设备及验证(8.9%)；对补正资料意见具体内容进行分析，中药品种存在问题主要集中在生产过程控制、中间体的质量对比研究和稳定性研究部分；化学原料药的起始物料和关键物料的质量标准、过程控制参数部分的补充资料要求较多；化学药品在立题合理性、质量研究部分存在较多补充资料要求。结论：对技术转移变更研究中存在准备不足、研究不充分的问题进行了分析，按申报品种的不同类别提出了研究建议。拟开展同类变更研究的申请人可以此为参考，在研究立项之时就应制定全面、规范的研究方案，提升变更研究的质量和效率。 |
| 英文摘要: |
| Objective: To provide references and suggestions for applicants of the change research of drug technology transfer. Methods: The supplementary data notifications issued by the Guangdong Drug Evaluation and Certification Center for drug technology transfer applications were collected, and statistical analysis of the opinions on the supplementary data in combination with the data classification and variety category were made. Results: 257 supplementary information of 59 requirements were analyzed, and most of which appeared in 5 aspects, namely the quality standards and analytic method validation(23.7%), quality contrast research (19.5%), production technology and process control (12.8%), control of materials(10.5%) and equipment and the validation (8.9%) . According to the different classifications of the application varieties, the problems of traditional Chinese medicine (TCM) mainly focus on process control, quality contrast research and stability study of intermediate. Most requirements for Active Pharmaceutical Ingredient (API) were extend to the quality standards of starting material, and control parameters of the process. There are many supplementary information requirements for the rationality and quality research of chemicals. Conclusion: Aiming at the technology transfer applicants’ lack of information and research, this paper offers rational recommendations according to the different classifications of the application varieties. Researchers and applicants that plan to carry out change research of drug technology transfer may take this as a reference, and should make comprehensive and regulated research programs at the establishment of the change research, so as to improve the quality and efficiency of the change research. |
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