—对主要研究结果的总结及评价撰写格式和要求.pdfVIP

—对主要研究结果的总结及评价撰写格式和要求.pdf

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—对主要研究结果的总结及评价撰写格式和要求

中药、天然药物综述资料撰写的格式和内容的 技术指导原则 ——主要研究结果的总结和评价 二 OO 五年十一月 目 录 一、概述············································································································1 二、撰写格式和要求······································································································1 (一)中药、天然药物新药申请 ······················································································1 1.申请临床·····································································································1 1.1品种概况············································································································1 1.2主要研究结果的总结····································································································· 2 1.3综合分析与评价······················································································ 4 2.申请生产······························································································································· 6 2.1 品种概况································································································ ·6 2.2主要研究结果的总结··················································································· 7 2.2综合分析与评价································································································ 8 (二)已有国家标准的中成药和天然药物制剂的申请 ·········································· 10 1. 品种概况·················

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