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《药品经营质量管理规范(修订草案)》发布于《全国药品流通行业发展规划纲要(2011-2015年)》及《药品安全“十二五”规划》之后,承扬了政策的基本宗旨,表达出对药品质量和安全的高度关注。“千呼万唤始出来”。经过12年的酝酿,新版《药品经营质量管理规范》终于面世,但仍打着“修订草案”的烙印。尽管如此,这版GSP草案提交的答卷倒也令人满意:纵向看,较现行《药品经营质量管理规范》(以下简称“现行GSP”)实现了大幅的跨越;横向看,较西方国家药品流通管理标准的差距在
The “Good Manufacturing Practices (Revised Draft)” was promulgated on the basis of the “Tenth Five-Year Plan of Pharmaceutical Safety” issued by the “Outline for the Development of the National Pharmaceutical Circulation Industry (2011-2015)” , Expressed a high degree of concern about the quality and safety of drugs. “Everlasting ”. After 12 years of deliberation, the new version of “Good Manufacturing Practices for Pharmaceutical Management” is finally available, but still stands for the imprint of “revised draft”. Nonetheless, the responses to this GSP draft are quite satisfactory: in the vertical view, they have achieved a substantial leapfrogging over the existing “Code of Practice for Pharmaceutical Business Management” (hereinafter referred to as “the current GSP”); in the horizontal view, Differences in the standards of pharmaceutical distribution management