中药、天然药物申请临床研究的医学理论及文献资料撰写原则

【Z】GCL1-1指导原则编号：中药、天然药物申请临床研究的医学理论及文献资料撰写原则二〇〇五年三月目录一、概述.··················································································································································1二、撰写的基本要.····························································································································1（一）处方组成，功能、主治病证（适应症）·······························································2（二）立题目的·····································································································································2（三）立题依据·····································································································································21、处方来源·············································································································································22、对主治病证病因病机、治法与处方的论述···································································23、文献综述···········································································································································3（四）对申报品种创新性、可行性分析················································································31、国内外相关品种研究、生产、使用现状的分析························································32、和已有国家标准的同类品种的比较··················································································33、可行性分析····································································································································3三、参考文献·········································································································································4四、著者·················································································································································41《中药、天然药物申请临床研究的医学理论及文献资料撰写原则》一、概述本撰写原则主要是中药、天然药物注册中申请临床研究时撰写医学理论及文献资料的基本要求。中药、天然药物与化学合成药物的新药研究与开发有很大的不同，一般而言，在进行药学、药理和临床等试验研究前，大多在安全性和有效性方面已经具有一定的研究基础，而这些支持药物安全性和有效性的研究基础是影响药物研究与开发前景、开发风险的重要因素，也是药品审评中比较关注的问题。认真研究、总结和分析已有的研究基础，是中药、天然药物研发工作的重要研究内容，也是药品审评机构结合药物临床前药学、药理研究结果综合判断药物能否进入临床研究的重要依据之一，因此，有必要明确中药、天然药物医学理论及文献资料撰写的基本要求。二、撰写的基本要求撰写医学理论及文献资料的目的在于说明已有研究基础对研制药物拟主治病证（适应症）的安全性、有效性的支持程度，应反映其研究基础、研究目的、研究思路和研究过程。应该突出中医药特色，强调中医药理论的指导作用和中医临床应用经验的支持作用。根据《药品注册管理办法》附件一“中药、天然药物注册分类及申报资料技术要求”，这部分内容主要是注册申报资料3的“立题目的与依据”。包括处方来源和选题依据，有关传统中医理论、古籍文献、国内外研究现1状或生产、使用情况的资料综述，以及对该品种创新性、可行性等的分析，包括和已有国家标准的同类品种的比较。（一）处方组成，功能、主治病证（适应症）应规范表述处方组成、各药味剂量，功能、主治（适应症），拟定的用法用量。中药制剂应根据本品的组方特点和中医药组方理论，确定其合理的功能、主治，用中医术语表述。天然药物制剂可以根据现代药理研究结论拟定。拟定的主治病证（适应症）一般应注意对中西医疾病、病情、分期、分型、中医证候等方面的合理限定。（二）立题目的应明确该品种的研发目的，其论述应该明确、具体。拟定的主治病证（适应症）或适用的人群，应考虑新药研究的可操作性，并符合临床实际。应提供所拟定的适应病证的流行病学资料，目前的治疗现状，存在的问题，本品拟解决的问题、作用特点和本立题的意义。（三）立题依据1、处方来源应详细说明处方来源、应用、筛选或演变过程及筛选的依据等情况。来源于古方的应该详细说明其具体出处、演变情况，现在的认识及其依据。已有临床应用经验的应该根据实际应用情况提供有效性和安全性方面的信息，根据不同的申报类别和品种可应用动物或/和人体的药效、毒理和临床的文献资料或正式新药研究前的处方筛选中的试验研究资料来说明。2、对主治病证病因病机、治法与处方的论述2中药制剂应用中医药理论对主治病证的病因病机、治法进行论述，并对处方的基本配伍原则（如君、臣、佐、使等）及组成药物或成份加以分析，以说明组方的合理性。天然药物制剂应结合已有的研究资料对拟定适应症提供依据并加以阐述。注意药物作用特点应与适应症的病情、分期、分型等方面相适应，说明拟定适应症的合理性，并反映其下一步临床研究的思路。3、文献综述应围绕制剂的研究目的，从主治病证（适应症）、处方用药等方面进行古今文献综述，以进一步说明立题依据的科学性。应注意引用文献资料的真实性及针对性，并注明出处，注意文献的可信度和资料的可靠性。申报中药材、新的药用部位制成的制剂、中药材代用品、天然药物等应重点围绕立题依据提供其古今文献综述。（四）对申报品种创新性、可行性分析1、国内外相关品种研究、生产、使用现状的分析应提供国内外与本品主治病证（适应症）相同或相近品种的研究、生产、使用现状的分析资料，以及与本品的处方组成相近药物的国内外研究、生产、使用现状的分析资料，以说明其创新性。2、和已有国家标准的同类品种的比较应提供和已有国家标准的同类品种的比较资料，以说明其特点和开发意义。3、可行性分析应从本项研究理论依据的科学性、处方组成的合理性、进一步研究的3可操作性以及市场前景的预测等方面加以论述。三、参考文献1、ICH注册技术资料汇编2、《药品注册管理办法》（试行）（2002年）3、《药物临床试验质量管理规范》（2003年）四、著者《中药、天然药物申请临床研究的医学理论及文献资料撰写原则》课题研究组4