必威体育精装版ICH指导原则精要.ppt

Cross-cutting Topics Cross-cutting Guidelines Some ICH Products do not fit uniquely into one of the Quality, Safety or Efficacy categories. Those Products can be found under the?Mulidisciplinary?Section. 三、Efficacy Guidelines 有效性评价指导原则 The work carried out by ICH under the Efficacy heading is concerned with the design, conduct, safety and reporting of clinical trials. It also covers novel types of medicines derived from biotechnological processes and the use of pharmacogenetics/genomics techniques to produce better targeted medicines E1 Clinical Safety for Drugs used in Long-Term Treatment用于长期治疗药物的临床安全性 E1 The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life Threatening Conditions要评估用于非危及生命的疾病的长期治疗药物的临床安全性人群暴露程度 E2A - E2F Pharmacovigilance药物警戒 E2A Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2B(R3) Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports E2B(R3) IWGImplementation: Electronic Transmission of Individual Case Safety Reports E2C(R2) Periodic Benefit-Risk Evaluation Report E2C(R2) -E2F E2C(R2) QAsQuestions Answers: Periodic Benefit-Risk Evaluation Report E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting E2E Pharmacovigilance Planning E2F Development Safety Update Report E3 Clinical Study Reports临床研究报告 E3 Structure and Content of Clinical Study Reports E3 QAs R1Questions Answers: Structure and Content of Clinical Study Reports  E4 Dose-Response Studies剂量反应研究 E4 Dose-Response Information to Support Drug Registration支持药品注册的剂量反应信息 E5 Ethnic Factors民族因素 E5(R1)Ethnic Factors in the Acceptability of Foreign Clinical Data E5 QAs (R1) Questions Answers: Ethnic Factors in the Acceptability of Foreign Clinical Data E6 Good Clinical Practice临床试验规范 E6(R1)Good Clinical Practice E6(R2)Addendum: Good Clinical Practice E7 Clinical Trials in Geriatr