电脑桌面
添加小米粒文库到电脑桌面
安装后可以在桌面快捷访问

Q3A(R2)-新原料药中的杂质(中英文)VIP免费

Q3A(R2)-新原料药中的杂质(中英文)_第1页
1/22
Q3A(R2)-新原料药中的杂质(中英文)_第2页
2/22
Q3A(R2)-新原料药中的杂质(中英文)_第3页
3/22
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USEICH HARMONISED TRIPARTITE GUIDELINEIMPURITIES IN NEW DRUG SUBSTANCESQ3A(R2)Current Step 4 versiondated 25 October 2006This 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 recommended for adoption to the regulatory bodies of the European Union, Japan and USA.Q3A(R2)Document HistoryFirst CodificationHistoryDateNew CodificationNovember 2005Q3Approval by the Steering Committee under Step 2 and release for public consultation.15March 1994Q3AQ3AApproval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.Q3 was renamed Q3A.30March 1995Q3AQ3A(R)Approval by the Steering Committee of the first Revision under Step 2 and release for public consultation.7October 1999Q3A(R1)Q3A(R)Approval by the Steering Committee of the first Revision under Step 4 and recommendation for adoption to the three ICH regulatory bodies.6 February 2002Q3A(R1)Current Step 4 versionQ3A(R2)Approval by the Steering Committee of the revision of the Attachment 2 directly under Step 4 without further public consultation.25 October 2006Q3A(R2)IMPURITIES IN NEW DRUG SUBSTANCESICH Harmonised Tripartite GuidelineHaving reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 7 February 2002, this guideline is recommended for adoption to the three regulatory parties to ICH.Attachment 2 has been revised on 25 October 2006.TABLE OF CONTENTS1.PREAMBLE..............................................................................................

1、当您付费下载文档后,您只拥有了使用权限,并不意味着购买了版权,文档只能用于自身使用,不得用于其他商业用途(如 [转卖]进行直接盈利或[编辑后售卖]进行间接盈利)。
2、本站所有内容均由合作方或网友上传,本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺!文档内容仅供研究参考,付费前请自行鉴别。
3、如文档内容存在违规,或者侵犯商业秘密、侵犯著作权等,请点击“违规举报”。

碎片内容

Q3A(R2)-新原料药中的杂质(中英文)

确认删除?
VIP
微信客服
  • 扫码咨询
会员Q群
  • 会员专属群点击这里加入QQ群
客服邮箱
回到顶部