Q4B Annex 6(R1) Step2.docVIP

INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE Draft Consensus Guideline Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Q4B Annex 6(R1) Current Step 2 version dated 27 September 2010 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 Steering Committee to the regulatory authorities of the three ICH regions (the European Union, Japan and the USA) for internal and external consultation, according to national or regional procedures.  Q4B Annex 6(R1)Document History Code History Date Q4B Annex 6 Approval by the Steering Committee under Step 2 and release for public consultation. 13 November 2008 Current Step 2 version Q4B Annex 6(R1) Integration of the Health Canada Interchangeability Statement under Section 4.5 after approval by the Steering Committee. 27 September2010 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Draft ICH Consensus Guideline Released for Consultation on 13 November 2008, at Step 2 of the ICH Process (This draft annex was revised -R1- to include the Interchangeability Statement from Health Canada on September 27, 2010) 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 2 4. CONSIDERATIONS FOR IMPLEMENTATION 2 4.1 General Consideration 2 4.2 FDA Consideration 2 4.3 EU Consideration 2 4.4 MHLW Consideration 2 4.4 Health Canada Consideration 2 5. REFERENCES USED FOR THE Q4B EVALUATION 3 Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions on Uniformity of Dosage Units General Chapter Q4B Annex 6(R1) 1. INTRODUCTION This annex is the result of the Q4B process for Uniformity of Do