Q4B Annex 6 Uniformity of Dosage Units General ChapterQ4B附录6 统一剂量单位常规篇

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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL

REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE

ICH HARMONISED TRIPARTITE GUIDELINE

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

TEXTS FOR USE IN THE ICH REGIONS

UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER

Q4B ANNEX 6

Current

Step 4

version

dated 13 November 2013

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.

Q4B Annex 6

Document History

Code

History

Date

Q4B Annex 6

Approval by the Steering Committee under

Step 2

and release

for public consultation.

13 November

2008

Q4B Annex

6(R1)

Integration into

Step 2

of the Health Canada

Interchangeability Statement under Section 4.5 after

approval by the Steering Committee.

27 September

2010

Current

Step 4

version

Q4B Annex 6

Approval by the Steering Committee under

Step 4

and

recommendation for adoption to the three ICH regulatory

bodies. The R was removed from the name of the document as

this is the first version of the Annex 6

Step 4.

13 November

2013

EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL

TEXTS FOR USE IN THE ICH REGIONS

UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER

Q4B ANNEX 6

ICH Harmonised Tripartite Guideline

Having reached

Step 4

of the ICH Process at the ICH Steering Committee meeting on 13

November 2013, this guideline is recommended for adoption

to the three regulatory parties to ICH.

TABLE OF CONTENTS

1. INTRODUCTION...................................................................................................... 1

2. Q4B OUTCOME ........................................................................................................ 1

2.1 Analytical Procedures .................................................................................................... 1

2.2 Acceptance Criteria ....................................................................................................... 1

3. TIMING OF ANNEX IMPLEMENTATION .............................................................. 1

4. CONSIDERATIONS FOR IMPLEMENTATION ...................................................... 1

4.1 General Consideration ................................................................................................... 1

4.2 FDA Consideration ........................................................................................................ 1

4.3 EU Consideration .......................................................................................................... 2

4.4 MHLW Consideration .................................................................................................... 2

4.5 Health Canada Consideration ....................................................................................... 2

5. REFERENCES USED FOR THE Q4B EVALUATION ............................................. 2

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INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEEVALUATIONANDRECOMMENDATIONOFPHARMACOPOEIALTEXTSFORUSEINTHEICHREGIONSONUNIFORMITYOFDOSAGEUNITSGENERALCHAPTERQ4BANNEX6CurrentStep4versiondated13November2013ThisGuide...

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