| 引用本文: | 沈黎新,钟元华,沈莉,董作军.新版药品GMP实施效果调查与分析[J].中国现代应用药学,2018,35(3):436-439. |
| SHEN Lixin,ZHONG Yuanhua,Shen Li,DONG Zuojun.Investigation and Analysis of New Drugs GMP Implementation Effect[J].Chin J Mod Appl Pharm(中国现代应用药学),2018,35(3):436-439. |
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| 摘要: |
| 目的 调查我国新版药品GMP的实施效果，分析存在的问题并提出相应对策建议。方法 采用文献研究、问卷调查等方法，向药品行业人员发放问卷，调查内容涉及法制建设、执法队伍、执法监督和监管环境等方面。结果 通过问卷调查，大部分受访者认为目前的法规协调性和实用性有待提高；检查员专业性和管理需加强；执法尺度需统一，检查信息公开不足；对是否取消认证制度仍存在一定疑虑。结论 药品监管部门可加强法制建设，提高工作效率；加强检查员培训，逐步实现专职化；完善执法监督机制，提高检查公开程度；优化资源配置，营造良好监管环境。 |
| 关键词: 药品监管 生产质量管理规范 检查员 执法 问卷调查 |
| DOI：10.13748/j.cnki.issn1007-7693.2018.03.030 |
| 分类号:R951 |
| 基金项目:浙江省软科学研究项目（2017C35052） |
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| Investigation and Analysis of New Drugs GMP Implementation Effect |
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SHEN Lixin1, ZHONG Yuanhua2, Shen Li3, DONG Zuojun2
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1.Zhejiang Institute of Medical Device Testing, Hangzhou 310018, China;2.College of Pharmaceutical Science, Zhejiang University of Technology, Hangzhou 310014, China;3.Senofi Hangzhou Pharmaceutical Co., Ltd., Hangzhou 310051, China
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| Abstract: |
| OBJECTIVE To investigate implementation effect of new drugs GMP, analyse problems and propose policy suggestions. METHODS Literature review and questionnaire survey were adopted. The questionnaire included legal construction, law enforcement personnel, supervision and environment. RESULTS Through the questionnaire survey, most respondents thought that regulatory harmonization and practicability should be improved. Speciality and management of inspector should be enhanced. Enforcement was not unified, and information disclosure was insufficient. Some respondents still doubt whether the GMP certification should be eliminated. CONCLUSION Drug administration can strengthen legal construction and raise working efficiency; enhance training and gradually realize full-time inspector; improve enforcement supervision and disclose the inspection information; optimize the resource distribution and set up a favorable environment. |
| Key words: drug administration GMP inspector law enforcement questionnaire survey |
