文档介绍：版本号:001 翻译时间:2015-12 翻译者:小林邮箱:xaolin77@ Page 1/40 INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE 人用药物注册技术要求国际协调委员会 ICH HARMONISED TRIPARTITE GUIDELINE ICH 三方协调指导原则 PHARMACEUTICAL DEVELOPMENT 药物开发 Q8(R2) Current Step 4 versiondated August 2009 当前Step 4版本发表于2009年8月 This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is mended for adoption to the regulatory bodies of the European Union, Japan and USA. 本指导原则由相应的ICH专家工作团队起草,并且已就ICH流程的一致性咨询了法规部门。在流程的Step 4,建议本最终版适用于欧盟、日本和美国的法规机构。版本号:001 翻译时间:2015-12 翻译者:小林邮箱:xaolin77@ Page 2/40 Q8(R2) Document History文件日志 First Codification 第一版 History 历史 Date 日期 Parent Guideline: Pharmaceutical development 主指导原则:药物开发 Q8 Approval of the Guideline by the mittee under Step 2 and release for public consultation. 本指导原则由Step 2下的专家委员会批准、释放以进入公开咨询阶段。 18 November 2004 Q8 Approval of the Guideline by the mittee under Step 4 and mendation for adoption to the three ICHregulatory bodies. 本指导原则由Step 4下的专家委员会批准并推荐适用于ICH三方法规机构。 10 November 2005 Annex to the Parent Guideline: Pharmaceutical Development 主指导原则附件:药物开发 Annex to Q8 Approval of the Annex by the mittee under Step 2 and release for public consultation. 本附件由Step 2下的专家委员会批准并释放以进入公开咨询阶段。 1 November 2007 Annex to Q8 Approval of the Annex by the mittee under Step 4 and mendation for adoption to the three ICH regulatory bodies. 本指导原则由Step 4下的专家委员会批准并推荐适用于ICH三方法规机构。 13 November 2008 Addition of Annex to the Parent Guideline 主指导原则附件指南 Q8(R1) The parent guideline “Pharmaceutical Development” was recoded Q8(R1) following the addition of the Annex to the parent guideline. 主指导原则“药品开发”在增加附件后的版本记录为Q8(R1)。 November 2008 Current Step 4 version 当前Step 4版本 Q8(R2) Corrigendum to titles of “Figure 2a”and “Figure 2b” of “Example 2” on page 23