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首页> 美国政府科技报告 >M4: Common Technical Document. Modules IIA, IIB Nonclinical, Module III, Quality,211 Modules IV, Nonclinical Module V, Efficacy. International Conference on 211 Harmonisation of Technical Requirements for Registration of Pharmaceuticals for 211 Human Use
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M4: Common Technical Document. Modules IIA, IIB Nonclinical, Module III, Quality,211 Modules IV, Nonclinical Module V, Efficacy. International Conference on 211 Harmonisation of Technical Requirements for Registration of Pharmaceuticals for 211 Human Use

机译：m4：通用技术文件。模块IIa，IIB非临床，模块III，质量，211模块IV，非临床模块V，功效。 211人类使用药品注册技术要求协调国际会议

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The International Conference on Harmonization(ICH) process has achieved211u001esignificant harmonization of the technical requirements for the registration of 211u001epharmaceuticals for human use in the three ICH regions. However, the regulatory 211u001esubmission documentation had not been examined, and there are currently 211u001esignificantly different requirements in each region for the composition and 211u001eorganization of the registration documents. The ICH M4 topic, The Common 211u001eTechnical Document, addresses this issue. Three Expert Working Groups for 211u001eQuality, Safety and Efficacy are developing guidelines for the Common Technical 211u001eDocument. The ICH Steering Committee is controlling the work on this topic by the 211u001euse of milestones to reflect the stages of completion that this work is moving 211u001ethrough, and wish to ensure that this process is transparent. As part of this 211u001etransparency it is considered important that as these milestones are achieved the 211u001edocument be disseminated widely for consultation. The document is hence being 211u001epublished for consultation as scientific consensus of the ICH parties on the 211u001ecomponent parts is reached, with these documents providing the framework and 211u001ebasis for the development of the final complete Guideline on the Common Technical 211u001eDocument.

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