| 杨东升,牛剑钊,许鸣镝.欧美GMP数据库在我国仿制药参比制剂遴选方面的应用[J].中国药事,2021,35(4):406-414 |
| 欧美GMP数据库在我国仿制药参比制剂遴选方面的应用 |
| The Application of USA and EU GMP Database in the Selection for Reference Preparations of Generic Drugs in China |
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| DOI：10.16153/j.1002-7777.2021.04.007 |
| 中文关键词: 参比制剂 生产质量管理规范 仿制药 遴选 橙皮书 |
| 英文关键词: reference preparations standard for production quality management generic drugs selection orange books |
| 基金项目:科技部“十三五重大新药创制”《药物一致性评价关键技术与标准研究》资助项目(编号 2017ZX09101001) |
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| 中文摘要: |
| 目的：通过调查参比制剂生产企业的GMP符合状态，判断确定其产品质量与可及性的影响。方法：概述美国和欧盟GMP的法律法规基础以及相关GMP数据库应用的情况，并以我国仿制药参比制剂目录(第一批)中收录的3个参比制剂拉米夫定片(0.1 g)、醋酸甲羟孕酮片(0.25 g)和佐匹克隆片(3.75 mg)为例，结合各品种药品说明书中提供的信息，分别介绍了在美国和欧盟GMP数据库中查询其生产企业的GMP符合状态的方法，进一步判断和确定其对参比制剂的质量和可及性影响。结果与结论：参比制剂生产企业的GMP符合状态是其产品质量和可及性的重要依据和保证，可以为国内制药企业和药品监管机构开展仿制药参比制剂的推荐、遴选和确定工作提供参考。 |
| 英文摘要: |
| Objective: By investigating the GMP compliance status of the manufacturers of reference preparations to judge and determine the impact of product quality and availability. Methods: This paper outlined the laws and regulations of GMP in the United States and the European Union and the application of related GMP database. By taking the three reference preparations——Lamivudine Tablets s (0.1 g), Medroxyprogesterone Acetate Tablets (0.25 g) and Zopiclone Tablets (3.75 mg) collected in the catalogue of reference preparations of generic drugs in China (first batch) as examples, it introduced the method of searching the GMP compliance status of the corresponding production enterprises in the GMP database of United States and European Union, combined with the information provided by the instructions for various kinds of drugs, and the influences on the quality and availability of the reference preparations were judged and determined. Results and Conclusion: The GMP compliance status of manufacturers of reference preparations is an important basis and guarantee for the quality and availability of their products, and it can provide references for domestic pharmaceutical enterprises and drug regulatory authorities to carry out the recommendation, selection and determination of referencepreparations of generic drugs. |
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