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ICH M4Q(R1): The Common Technical Document for …
ICH M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality GI025A gggmmmpppeeeyyyeee 1 INTERNATIONAL CONFERENCE ON HARMONISATION OF Technical REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE ICH HARMONISED TRIPARTITE GUIDELINE The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality M4Q(R1) Quality Overall Summary of Module 2 Module 3: Quality Current Step 4 version dated 12 September 2002 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 recommended for adoption to the regulatory bodies of the European Union, Japan and USA. ICH M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality GI025A gggmmmpppeeeyyyeee 2 M4Q(R1) Document History First Codification History Date New CodificationNovember 2005 M4Q Approval by the Steering Committee under Step 2 and release for public consultation20 July 2000 M4Q M4Q Approval by the Steering Committee under Step 4 and recommendation for adoption to the three IC
ICH M4Q(R1): The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality GI025A ggmmppeeyyee www.gmpeye.co.kr 2 M4Q(R1) Document History
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