| 吴浩,王惠华,周坛树.我国药用辅料的管理、风险因素分析及监管对策思考[J].中国药事,2022,36(3):268-272 |
| 我国药用辅料的管理、风险因素分析及监管对策思考 |
| Management, Risk Factors Analysis and Supervision Countermeasures of Pharmaceutical Excipients in China |
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| DOI：10.16153/j.1002-7777.2022.03.005 |
| 中文关键词: 药用辅料 风险因素分析 监管对策 药品上市许可持有人 GMP |
| 英文关键词: pharmaceutical excipients risk analysis supervision marketing authorisation holder (MAH) GMP |
| 基金项目: |
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| 摘要点击次数: 1271 |
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| 中文摘要: |
| 目的：防控药用辅料的风险，加强药用辅料管理。方法：结合药品行业现状，采用法规分析和文献调研法，梳理辅料管理风险因素，提出相应的监管对策。结果: 在我国实施辅料关联审评审批制度和药品上市许可持有人制度的背景下，介绍药用辅料管理概况，明确了药用辅料管理各环节风险因素，以及上市许可持有人对辅料供应商质量审计的主要事项。结论：药品上市许可持有人落实辅料质量的主体责任是关键。辅料生产企业要严格执行药用辅料生产质量管理规范，监管部门要加强对药品上市许可持有人和药用辅料生产企业的监管。 |
| 英文摘要: |
| Objective: To prevent and control the risks of pharmaceutical excipients, strengthen the management of pharmaceutical excipients. Methods：According to the current situation of the pharmaceutical industry, adopting analysis of laws and regulations and literature research method, the risk factors of pharmaceutical excipients management were sorted out, the supervision countermeasures of pharmaceutical excipients were put forward. Results：Under the implementation of pharmaceutical excipients related review system and Marketing Authorisation Holder(MAH)system, the general situation of pharmaceutical excipients management in China was introduced, the risk factors of each link of pharmaceutical excipients management were analyzed and the main issues of quality audit of pharmaceutical excipients supplier for MAH were clarified. Conclusion：It is important that the MAH should implement the main responsibility for the quality of pharmaceutical excipients. Pharmaceutical excipients production enterprises should strictly implement GMP. The regulatory authorities should strengthen the supervision of MAH and pharmaceutical excipients production enterprises. |
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