This document describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of a regulatory submission in the ICH M4 Common Technical Document (CTD) format.

1. INTRODUCTION This guideline is an annex to ICH Q8 Pharmaceutical Development and provides further clarification of key concepts outlined in the core guideline. In addition, this annex describes the principles of quality by design1 (QbD).

是否对非无菌药物制剂进行微生物检查及其理由（即：《ICH Q6A质量标准：新原料药和新药制剂的测试方法和认可标准：化学物质》中的决策树#8和《ICH Q6B质量标准：生物技术产品及生物制品的测试方法和认可标准》）；

2020年4月14日 · This guidance is a revision of the ICH guidance Q8 Pharmaceutical Development (Q8 parent guidance) that published in May 2006. In June 2009, the Q8 parent guidance was revised to add an annex,...

E8 General Considerations for Clinical Trials/临床试验的一般性考虑. E9 Statistical Principles for Clinical Trials/临床试验的统计原则. E10 Choice of Control Group in Clinical Trials/试验中对照 …

This document provides guidance on the implementation of ICH guidelines Q8, Q9 and Q10. It answers the questions about the current procedure of the ICH Quality Implementation Working Group on those guidelines.

如果制药厂商能够结合适当的药品质量体系,采用质量源于设计和质量风险管理(ICH Q9:质量风险管理),就会有助于推进以科学和风险为基础的管理模式(见ICH Q10,药品质量体系)。

ICH指导原则 (cde.org.cn) Q8 (R2):药品研发下表从药品研发和生命周期管理的不同方面，将基本研 发方案与加强型，质量源于设计的研发方案进行了对比。

2015年12月3日 · This guideline describes the suggested contents for the 3.2.P.2 (Pharmaceutical Development) section of regulatory submission in the ICH M4 Common Technical Document (CTD) format. 本指导原则描述了在ICH M4通用技术文件（CTD）模板中法规要求提交的3.2.P.2 (药物开发)部分 所建议的内容。

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of …