Q3A(R2)-新原料药中的杂质(中英文)

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH H ARMONISED T RIPARTITE G UIDELINE

I MPURITIES I N N EW D RUG S UBSTANCES

Q3A(R2)

Current Step 4 version

dated 25 October 2006

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.

Q3A(R2) Document History

Current Step 4 version

I MPURITIES I N N EW D RUG S UBSTANCES

ICH Harmonised Tripartite Guideline

Having 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 CONTENTS

1.PREAMBLE (4)

2.CLASSIFICATION OF IMPURITIES (4)

3.RATIONALE FOR THE REPORTING AND CONTROL

OF IMPURITIES (6)

3.1Organic Impurities (6)

3.2Inorganic Impurities (7)

3.3Solvents (7)

4.ANALYTICAL PROCEDURES (8)

5.REPORTING IMPURITY CONTENT OF BATCHES (9)

6.LISTING OF IMPURITIES IN SPECIFICATIONS (10)

7.QUALIFICATION OF IMPURITIES (12)

8.GLOSSARY (14)

ATTACHMENT 1 (17)

ATTACHMENT 2 (18)

ATTACHMENT 3 (20)

I MPURITIES I N N EW D RUG S UBSTANCES

新原料药中的杂质

1. PREAMBLE 序言

This document is intended to provide guidance for registration applications on the content and qualification of impurities in new drug substances produced by chemical syntheses and not previously registered in a region or member state. It is not intended to apply to new drug substances used during the clinical research stage of development. The following types of drug substances are not covered in this guideline: biological/biotechnological, peptide, oligonucleotide, radiopharmaceutical, fermentation product and semi-synthetic products derived therefrom, herbal products, and crude products of animal or plant origin.

本文件旨在为化学合成的新原料药（这些新原料药尚未在任何地区或成员国注册）在注册申请时，对其杂质的含量和界定的申报提供指导。本报导原则不适用于临床研究期间所用的新原料药。本文件不涵盖生物／生物制品、肽、寡聚核苷酸。放射性药物、发酵和半合成产品、草药以及来源于动、植物的粗制品。

Impurities in new drug substances are addressed from two perspectives:

新原料药中的杂质分两个方面阐述：

Chemistry Aspects include classification and identification of impurities, report generation, listing of impurities in specifications, and a brief discussion of analytical procedures; and

化学方面：包括对杂质的分类和鉴定、杂质生成、规范中杂质的检查项目以及对分析方法的简要讨论。

Safety Aspects include specific guidance for qualifying those impurities that were not present, or were present at substantially lower levels, in batches of a new drug substance used in safety and clinical studies.

安全性方面：对用于安全性研究和临床研究的新原料药批次中不存在或含量很低的那些杂质的界定的指南。

2. CLASSIFICATION OF IMPURITIES 杂质的分类

Impurities can be classified into the following categories: 杂质可分为下列类型:

∙Organic impurities (process- and drug-related) 有机杂质（与工艺和药物有关的）

∙Inorganic impurities 无机杂质

∙Residual solvents 残留溶剂