中国药物警戒 ›› 2012, Vol. 9 ›› Issue (7): 418-420.

• 政策与法规研究 • 上一篇    下一篇

药品再注册技术审评要点分析及思考

刘金霞   

  1. 河南省药品审评认证中心,河南 郑州 450000
  • 收稿日期:2011-12-30 出版日期:2012-07-10 发布日期:2015-08-07
  • 作者简介:刘金霞,女,高级工程师,药品技术审评。

Analysis and Reflection on Technological Examination for License Renew Application of Drugs

LIU Jin-xia   

  1. Centre for Drug Evaluation and Certification of Henan, Henan Zhengzhou 450000, China
  • Received:2011-12-30 Online:2012-07-10 Published:2015-08-07

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摘要： 目的继续完善再注册工作,更好地发挥其在药品监管中的作用。方法对药品再注册工作的技术审评要点包括生产许可范围、质量标准、不良反应等进行归纳和分析。结果与结论 政策法规的进一步完善, “申报”、“审评”质量的提高,对再注册工作的更加完善有着重要意义。

关键词: 药品再注册, 技术审评, 分析思考

Abstract: ObjectiveTo improve the examining process of license renew application for supervision and management of drugs. MethodsThe main points of technological examination for drug license renew application were summarized and analyzed, including the range of production permit, quality standards, adverse reactions and so on. Resultsand ConclusionThe improvement of quality of evaluation and policy and regulations play an important role in license renew application.

Key words: drug license renew application, technical examination, analysis and reflection