ICH M4Q(R2) 质量指南：人用药品注册通用技术文档 (CTD)：质量

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INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL

REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED GUIDELINE

THE COMMON TECHNICAL DOCUMENT FOR

THE REGISTRATION OF PHARMACEUTICALS

FOR HUMAN USE: QUALITY

M4Q(R2)

Draft version

Endorsed on 14 May 2025

Currently under public consultation

At Step 2 of the ICH Process, a consensus draft text or guideline, agreed by the

appropriate ICH Expert Working Group, is transmitted by the ICH Assembly to the

regulatory authorities of the ICH regions for internal and external consultation,

according to national or regional procedures.

M4Q(R2)

Document History

Code

History

Date

M4Q(R2)

Endorsement by the Members of the ICH

Assembly under Step 2 and release for public

consultation.

14 May 2025

Legal notice: This document is protected by copyright and may, with the exception of the ICH

logo, be used, reproduced, incorporated into other works, adapted, modified, translated or

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were made to or based on the original document. Any impression that the adaption,

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The above-mentioned permissions do not apply to content supplied by third parties. Therefore,

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obtained from this copyright holder.

iii

ICH HARMONISED GUIDELINE

THE COMMON TECHNICAL DOCUMENT FOR THE

REGISTRATION OF PHARMACEUTICALS FOR

HUMAN USE: QUALITY

M4Q(R2)

ICH Consensus Guideline

TABLE OF CONTENTS

SCOPE AND ORGANISATION ...................................................................................................... 1

MODULE 2. COMMON TECHNICAL DOCUMENT SUMMARIES ....................................... 4

2.3. Quality Overview ..........................................................................................................................4

2.3.1 General Information....................................................................................................................4

2.3.2 Overall Development and Overall Control Strategy.................................................................. 4

2.3.2.1 Quality Target Product Profile ...................................................................................... 4

2.3.2.2 Overall Development Strategy ...................................................................................... 5

2.3.2.3 Overall Control Strategy Representation ...................................................................... 5

2.3.3 Core Quality Information........................................................................................................... 5

2.3.3.DS Drug Substances.........................................................................................................5

2.3.3.SI Substance Intermediates, if Applicable ........................................................................ 8

2.3.3.SM Starting/Source Materials .......................................................................................... 9

2.3.3.RM Raw Materials ............................................................................................................9

2.3.3.EX Excipients................................................................................................................. 10

2.3.3.RS Reference Standards and/or Materials ......................................................................11

2.3.3.DP Drug Products .......................................................................................................... 12

2.3.3.PI Product Intermediates, if Applicable ......................................................................... 14

2.3.3.MD Medical Devices, if Applicable ................................................................................14

2.3.3.PM Packaged Medicinal Products for multiconstituent products, if Applicable........... 16

2.3.3.PH Pharmaceutical Product after transformation, if Applicable.................................. 17

2.3.3.AP Analytical Procedures ...............................................................................................17

2.3.3.FA Facilities....................................................................................................................18

2.3.4 Development Summary and Justification .................................................................................18

2.3.4.IN Integrated Development and Justifications ...............................................................18

2.3.4.DS Drug Substances.......................................................................................................20

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