ICH 指导原则文件目录中英文.docxVIP

人用药品注册技术要求国际协调会（ICH）文件目录ICH的论题主要分为四类，因此ICH根据论题的类别不同而进行相应的编码分类：?1.?“Q”类论题：Q代表QUALITY，指那些与化工和医药，质量保证方面的相关的论题。Q1/Q2...Q10都属于这类。?2.?“S”类论题：S代表SAFETY，指那些与实验室和动物实验，临床前研究方面的相关的论题。?3.?“E”类论题：E代表EFFICACY，指那些与人类临床研究相关的课题。?4.?“M”类论题：M代表MULTIDISCIPLINARY,?指那些不可单独划入以上三个分类的交叉涉及的论题。同时M又细分为5个小类?：M1:?常用医学名词?（MedDRA）?M2:?药政信息传递之电子标准?M3:?与临床试验相关的临床前研究时间的安排?M4:?常规技术文件(CTD)?M5:?药物词典的数据要素和标准一、ICH.质量部分（Quality）?稳定性??Quality质量??Q1:?Stability稳定性?Q1A(R2):?Stability?Testing?of?New?Drug?Substances?and?Products??新原料药和制剂的稳定性试验?Q1B:?Photostability?Testing?of?New?Drug?Substances?and?Products?新原料药和制剂的光稳定性试验?Q1C:?Stability?Testing?for?New?Dosage?Forms?新剂型的稳定性试验?Q1D:?Bracketing?and?Matrixing?Designs?for?Stability?Testing?of?Drug?Substances?and Drug?Products?原料药和制剂稳定性试验的交叉和矩阵设计?Q1E:?Evaluation?of?Stability?Data?稳定性数据的评估?Q1F:?Stability?Data?Package?for?Registration?Applications?in?Climatic?Zones?III?and?IV??在气候带III和IV，药物注册申请所提供的稳定性数据Q2:?Analytical?Validation分析验证?Q2(R1):?Validation?of?Analytical?Procedures:?Text?and?Methodology?分析程序的验证：正文及方法论??Q3:?Impurities?杂质?Q3A(R2):?Impurities?in?New?Drug?Substances??新原料药中的杂质?Q3B(R2):?Impurities?in?New?Drug?Products?(Revised?Guideline)?新制剂中的杂质?Q3C(R3):?Impurities:?Guideline?for?Residual?Solvents?杂质：残留溶剂指南?Impurities:?Guideline?for?Residual?Solvents?(Maintenance)?杂质：残留溶剂指南(保留)?PDE?for?Tetrahydrofuran?(in?Q3C(R3))???????????四氢呋喃的日允许接触剂量?PDE?for?N-Methylpyrrolidone?(in?Q3C(R3))?????????N-甲基吡咯烷酮的日允许接触剂量?Q4:?Pharmacopoeias药典?Q4A:?Pharmacopoeial?Harmonisation?药典的协调?Q4B:?Evaluation?and?Recommendation?of?Pharmacopoeial?Texts?for?Use?in?the?ICH?Regions?药典内容的评估及推荐为用于ICH地区?Q4B?Annex1?Evaluation?and?Recommendation?of?Pharmacopoeial?Texts?for?Use?in?the?ICH?Regions?on?Residue?on?Ignition/Sulphated?Ash?General?Chapter?附录1?药典内容的评估及推荐为用于ICH地区?关于灼烧残渣/灰分?常规篇?Q4B?Annex2?Evaluation?and?Recommendation?of?Pharmacopoeial?Texts?for?Use?in?the?ICH?Regions?on?Test?for?Extractable?Volume?of?Parenteral?Preparations?General?Chapter?附录2?药典内容的评估及推荐为用于ICH地区?关于注射剂可提取容量测试?常规篇?Q4B?Annex3?Evaluation?a