序

进入21世纪，世界经济一体化加快推进，以和平、发展、合作、共赢为主题的新时代已经开启。2017年6月，我国正式成为“国际人用药品注册技术协调会（ICH）”成员，中国医药产业将置身于全球格局中参与竞争，中国药品监管机...

前言

1990年，欧洲共同体（简称欧共体，欧盟前身）、美国、日本三方政府兽药注册部门和兽药生产研发部门协商成立“兽药注册技术要求国际协调会（VICH）”，2015年，VICH由一个封闭的国际会议机制转变成为在瑞士民法下注册的...

化学药品

• 质量
• 安全性
• 有效性

生物制品

• 质量
• 安全性

附录　VICH缩略语

VICH缩略语VICH缩略语（续）-1

VICH GL39（QUALITY）November 2005 For implementation at Step 7

TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW VETERINARY DRUG SUBSTANCES AND NEW MEDICINAL PRODUCTS：CHEMICAL SUBSTANCESRecommended for Adoption at Step 7 of the VICH Process in November 20...

• 1 INTRODUCTION
• 2 GENERAL CONCEPTS
• 3 GUIDELINES
• 4 GLOSSARY
• 5 REFERENCES
• 6 ATTACHMENTS

VICH GL3（R）（QUALITY）January 2007 Revision at Step 9 For Implementation at Step 7

STABILITY：STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES（REVISION）Recommended for Adoption at Step 7 of the VICH Process in January 2007 by the VICH SC for implementation in January 200...

• 1 INTRODUCTION
• 2 GUIDELINES
• 3 GLOSSARY
• 4 REFERENCES

VICH GL4（STABILITY 2）May 1999 For implementation at Step 7

STABILITY TESTING FOR NEW VETERINARY DOSAGE FORMSRecommended for Implementation at Step 7 of the VICH Process on 20 May 1999 by the VICH Steering CommitteeThis Guideline has been developed b...

VICH GL5（STABILITY 3）May 1999 For implementation at Step 7

STABILITY TESTING：PHOTOSTABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTSRecommended for Implementation at Step 7 of the VICH Process on 20 May 1999 by the VICH Steer...

• 1 General
• 2 Drug Substance
• 3 Drug Product
• 4 Annex
• 5 Glossary
• 6 References

VICH GL 45（QUALITY）-BRACKETING AND MATRIXING April 2010 For Implementation at Step 7

QUALITY：BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTSAdopted at Step 7 of the VICH Process by the VICH Steering Committee in...

• 1 INTRODUCTION
• 2 GUIDELINES

VICH GL51（QUALITY：STABILITY DATA）February 2013 For Implementation at Step 7-Final

STATISTICAL EVALUATION OF STABILITY DATAAdopted at Step 7 of the VICH Process by the VICH Steering Committee in February 2013 for implementation by 28 February 2014.This Guideline has been d...

• 1 INTRODUCTION
• 2 GUIDELINES
• 3 APPENDICES

VICH GL10（QUALITY）January 2007 Revision at Step 9 For Implementation at Step 7

IMPURITIES IN NEW VETERINARY DRUG SUBSTANCES（REVISION）Recommended for Adoption at Step 7 of the VICH Process in January 2007 by the VICH SC for implementation in January 2008This Guideline h...

• 1 PREAMBLE
• 2 CLASSIFICATION OF IMPURITIES
• 3 RATIONALE FOR THE REPORTING AND CONTROL OF IMPURITIES
• 4 ANALYTICAL PROCEDURES
• 5 REPORTING IMPURITY CONTENT OF BATCHES
• 6 LISTING OF IMPURITIES IN SPECIFICATIONS
• 7 QUALIFICATION OF IMPURITIES
• 8 GLOSSARY

VICH GL11（QUALITY）January 2007 Revision at Step 9 For Implementation at Step 7

IMPURITIES IN NEW VETERINARY MEDICINAL PRODUCTS（REVISION）Recommended for Adoption at Step 7 of the VICH Process in January 2007 by the VICH SC for implementation in January 2008This Guidelin...

• 1 INTRODUCTION
• 2 RATIONALE FOR THE REPORTING AND CONTROL OF DEGRADATION PRODUCTS
• 3 ANALYTICAL PROCEDURES
• 4 REPORTING DEGRADATION PRODUCTS CONTENT OF BATCHES
• 5 LISTING OF DEGRADATION PRODUCTS IN SPECIFICATIONS
• 6 QUALIFICATION OF DEGRADATION PRODUCTS
• 7 GLOSSARY

VICH GL18（R）（IMPURITIES SOLVENTS）June 2011 Revision at Step 9 For Implementation at Step 7

IMPURITIES：RESIDUAL SOLVENTS IN NEW VETERINARY MEDICINAL PRODUCTS, ACTIVE SUBSTANCES AND EXCIPIENTS（REVISION）Adopted at Step 7 of the VICH Process by the VICH Steering Committee in June 2011...

• 1 INTRODUCTION
• 2 SCOPE OF THE GUIDELINE
• 3 GENERAL PRINCIPLES
• 4 LIMITS OF RESIDUAL SOLVENTS
• GLOSSARY
• APPENDIX 1：LIST OF SOLVENTS INCLUDED IN THE GUIDELINE
• APPENDIX 2：ADDITIONAL BACKGROUND
• APPENDIX 3：METHODS FOR ESTABLISHING EXPOSURE LIMITS

VICH GL1（VALIDATION DEFINITION）October 1998 For implementation at Step 7

VALIDATION OF ANALYTICAL PROCEDURES：DEFINITION AND TERMINOLOGYRecommended for Implementation at Step 7 of the VICH Process on 22 October 1998 by the VICH Steering CommitteeThis Guideline has...

• 1 Introduction
• 2 Types of Analytical Procedures to be Validated
• 3 GLOSSARY

VICH GL2（VALIDATION METHODOLOGY）October 1998 For implementation Step 7

VALIDATION OF ANALYTICAL PROCEDURES：METHODOLOGYRecommended for Implementation at Step 7 of the VICH Process on 22 October 1998 by the VICH Steering CommitteeThis Guideline has been developed...

• INTRODUCTION
• 1 SPECIFICITY
• 2 LINEARITY
• 3 RANGE
• 4 ACCURACY
• 5 PRECISION
• 6 DETECTION LIMIT
• 7 QUANTITATION LIMIT
• 8 ROBUSTNESS
• 9 SYSTEM SUITABILITY TESTING

VICH GL22（SAFETY：REPRODUCTION）Revision 1 May 2004 For implementation at Step 7

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：REPRODUCTION TESTINGRecommended for Implementation at Step 7 of the VICH Process on June 2001 by the VICH Steerin...

• 1 INTRODUCTION
• 2 GUIDELINE
• 3 REFERENCES

VICH GL23（R）（SAFETY）-GENOTOXICITY October 2014 Revision at Step 9 For implementation at Step 7

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：GENOTOXICITY TESTINGRevision at Step 9 Adopted at Step 7 of the VICH Process by the VICH Steering Committee in Se...

• 1 INTRODUCTION
• 2 STANDARD BATTERY OF TESTS
• 3 MODIFICATIONS TO THE STANDARD BATTERY
• 4 THE CONDUCT OF TESTS
• 5 ASSESSMENT OF TEST RESULTS
• 6 REFERENCES
• 7 GLOSSARY

VICH GL28（SAFETY：CARCINOGENITICY）Revision（at Step 9）February 2005 For implementation at Step 7

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：CARCINOGENICITY TESTINGRecommended for Adoption at Step 7 of the VICH Process in October 2004 by the VICH SC for ...

• 1 INTRODUCTION
• 2 CARCINOGENICITY ASSESSMENT
• 3 REFERENCES

VICH GL31（SAFETY：REPEAT-DOSE TOXICITY）Revision 1 May 2004 For implementation at Step 7-Final

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：REPEAT-DOSE（90 DAYS）TOXICITY TESTINGRecommended for Implementation on October 2002 by the VICH Steering Committee...

• 1 INTRODUCTION
• 2 GUIDELINE
• 3 REFERENCES

VICH GL32（SAFETY：DEVELOPMENTAL TOXICITY）Revision 1 May 2004 For implementation at Step 7-Final

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：DEVELOPMENTAL TOXICITY TESTINGRecommended for Implementation on October 2002 by the VICH Steering CommitteeEDITOR...

• 1 INTRODUCTION
• 2 GUIDELINE

VICH GL33（SAFETY：GENERALAPPROACH）Revision 2 at step 9 February 2009 For implementation at Step 7-Final

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：GENERAL APPROACH TO TESTINGRecommended for Adoption at Step 7 of the VICH Process in February 2009 by the VICH SC...

• 1 INTRODUCTION
• 2 GUIDELINES
• 3 REFERENCES

VICH GL37（SAFETY）May 2004 For implementation at Step 7-Final

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：REPEAT-DOSE CHRONIC TOXICITY TESTINGRecommended for implementation by May 2005 by the VICH SC at its meeting held...

• 1 INTRODUCTION
• 2 GUIDELINE
• 3 REFERENCES
• APPENDIX A

VICH GL54（SAFETY）-ARfD November 2016 For Implementation at Step 7

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：GENERAL APPROACH TO ESTABLISH AN ACUTE REFERENCE DOSE（ARfD）Adopted at Step 7 of the VICH Process by the VICH Stee...

• 1 Introduction
• 2 Guidance for an ARfD
• 3 Glossary
• 4 References
• 5 Annex Procedure for the Derivation of an Appropriate ARfD

VICH GL27（ANTIMICROBIAL RESISTANCE：PRE-APPROVAL）December 2003 For implementation at Step 7-Final

GUIDANCE ON PRE-APPROVAL INFORMATION FOR REGISTRATION OF NEW VETERINARY MEDICINAL PRODUCTS FOR FOOD PRODUCING ANIMALS WITH RESPECT TO ANTIMICROBIAL RESISTANCERecommended for Implementation a...

• 1 Basic information
• 2 Additional information
• 3 Discussion
• 4 Glossary
• 5 References

VICH GL36（R）（SAFETY-MICROBIOLOGICALADI）May 2012 Revision at Step 9 For Implementation at Step 7

STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD：GENERAL APPROACH TO ESTABLISH A MICROBIOLOGICAL ADIAdopted at Step 7 of the VICH Process by the VICH Steering Com...

• 1 INTRODUCTION
• 2 GUIDELINE
• 3 GLOSSARY
• 4 REFERENCES
• APPENDIX A
• APPENDIX B
• APPENDIX C
• APPENDIX D

VICH GL 43（TARGET ANIMAL SAFETY）-PHARMACEUTICALS July 2008 For implementation at Step 7

TARGET ANIMAL SAFETY FOR VETERINARY PHARMACEUTICAL PRODUCTSAdopted at Step 7 of the VICH Process by the VICH Steering Committee in July 2008 for implementation in July 2009This Guideline has...

• 1 INTRODUCTION
• 2 MARGIN OF SAFETY STUDIES
• 3 OTHER LABORATORY SAFETY STUDY DESIGNS
• 4 TARGET ANIMAL SAFETY DATA FROM FIELD STUDIES
• 5 RISK ASSESSMENT IN ANIMAL SAFETY EVALUATION
• 6 GLOSSARY

VICH GL 46（MRK）-METABOLISM AND RESIDUE KINETCIS February 2011 For Implementation at Step 7-Final

STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS：METABOLISM STUDY TO DETERMINE THE QUANTITY AND IDENTIFY THE NATURE OF RESIDUESAdopted at...

• 1 INTRODUCTION
• 2 GUIDANCE
• 3 REPORTING OF DATA
• 4 GLOSSARY

VICH GL 47（MRK）-METABOLISM AND RESIDUE KINETCIS February 2011 For Implementation at Step 7-Final

STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS：LABORATORY ANIMAL COMPARATIVE METABOLISM STUDIESAdopted at Step 7 of the VICH Process by...

• 1 INTRODUCTION
• 2 GUIDANCE
• 3 GLOSSARY

VICH GL 48（R）（MRK）-METABOLISM AND RESIDUE KINETCIS February 2015 Revision at Step 9 For implementation at Step 7-Final-Corrected

STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS：MARKER RESIDUE DEPLETION STUDIES TO ESTABLISH PRODUCT WITHDRAWAL PERIODSRevision at step...

• 1 INTRODUCTION
• 2 GUIDANCE
• 3 GLOSSARY

VICH GL 49（R）（MRK）-METABOLISM AND RESIDUE KINETCIS January 2015 Revision at Step 9 For implementation at Step 7-Final

STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD PRODUCING ANIMALS：VALIDATION OF ANALYTICAL METHODS USED IN RESIDUE DEPLETION STUDIESRevision at step 9 Ado...

• 1 INTRODUCTION
• 2 GUIDANCE
• 3 PERFORMANCE CHARACTERISTICS
• 4 GLOSSARY
• 5 Annex
• 6 Reference

VICH GL6（ECOTOXICITY PHASE I）June 2000 For implementation at Step 7

ENVIRONMENTAL IMPACT ASSESSMENT（EIAS） FOR VETERINARY MEDICINAL PRODUCTS（VMPS）-PHASE IRecommended for Implementation at Step 7 of the VICH Process on 15 June 2000 by the VICH Steering Committ...

VICH GL 38（ECOTOXICITY PHASE II）October 2004 For implementation at Step 7

ENVIRONMENTAL IMPACT ASSESSMENT FOR VETERINARY MEDICINAL PRODUCTS PHASE II GUIDANCERecommended for Adoption at Step 7 of the VICH Process in October 2004 by the VICH SC for implementation in...

• 1 INTRODUCTION
• 2 GENERAL ELEMENTS
• 3 RECOMMENDED STUDIES AT TIER AAND TIER B
• 4 AQUACULTURE BRANCH
• 5 INTENSIVELY REARED ANIMALS BRANCH
• 6 PASTURE ANIMALS BRANCH
• 7 GLOSSARY（DEFINITIONS OF TERMS）
• 8 OECD/ISO TEST GUIDELINES FOR RECOMMENDED STUDIES

VICH GL9（GCP）June 2000 For Implementation at Step 7

GOOD CLINICAL PRACTICERecommended for Implementation at Step 7 of the VICH Process on 15 June 2000 by the VICH Steering CommitteeThis Guideline has been developed by the appropriate VICH Exp...

• INTRODUCTION
• 1 GLOSSARY
• 2 THE PRINCIPLES OF VICH GCP
• 3 THE INVESTIGATOR
• 4 THE SPONSOR
• 5 THE MONITOR
• 6 THE STUDY PROTOCOL
• 7 THE FINAL STUDY REPORT
• 8 STUDY DOCUMENTATION

VICH GL 52（BIOEQUIVALENCE）AUGUST 2015 For implementation at Step 7

BIOEQUIVALENCE：BLOOD LEVEL BIOEQUIVALENCE STUDYAdopted at Step 7 of the VICH Process by the VICH Steering Committee in August 2015 for implementation by August 2016.This Guideline has been d...

VICH GL7（ANTHELMINTICS GENERAL）November 2000 For implementation at Step 7

EFFICACY OF ANTHELMINTICS：GENERAL REQUIREMENTS（EAGR）Recommended for Implementation at Step 7 of the VICH Process on 21 November 2000 by the VICH Steering CommitteeThis Guideline has been dev...

• A.General Elements
• B. Specific evaluation studies
• ACKNOWLEDGEMENTS

VICH GL12（ANTHELMINTICS：BOVINES）November 1999 For implementation at Step 7

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR BOVINESRecommended for Implementation at Step 7 of the VICH Process on 16 November 1999 by the VICH Steering CommitteeThis Guideline ha...

• A. General Elements
• B. Specific Evaluation Studies

VICH GL13（ANTHELMINTICS：OVINES）November 1999 For implementation at Step 7

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR OVINESRecommended for Implementation at Step 7 of the VICH Process on 16 November 1999 by the VICH Steering CommitteeThis Guideline has...

• A. General Elements
• B. Specific Evaluation Studies

VICH GL14（ANTHELMINTICS：CAPRINES）November 1999 For implementation at Step 7

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR CAPRINESRecommended for Implementation at Step 7 of the VICH Process on 16 November 1999 by the VICH Steering CommitteeThis Guideline h...

• A. General Elements
• B. Specific Evaluation Studies

VICH GL15（ANTHELMINTICS：EQUINE）June 2001 For implementation at Step 7-Draft 1

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR EQUINESRecommended for Implementation on June 2001 by the VICH Steering CommitteeThis Guideline has been developed by the appropriate V...

• A. General Elements
• B. Specific evaluation studies

VICH GL16（ANTHELMINTICS：PORCINE）June 2001 For implementation at Step 7-Draft 1

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR PORCINESRecommended for Implementation on June 2001 by the VICH Steering CommitteeThis Guideline has been developed by the appropriate ...

• A. General Elements
• B. Specific evaluation studies

VICH GL19（ANTHELMINTICS：CANINE）June 2001 For implementation at Step 7-Draft 1

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR CANINESRecommended for Implementation on June 2001 by the VICH Steering CommitteeThis Guideline has been developed by the appropriate V...

• A. General Elements
• B. Specific Evaluation Studies

VICH GL20（ANTHELMINTICS：FELINE）June 2001 For implementation at Step 7-Draft 1

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR FELINESRecommended for Implementation on June 2001 by the VICH Steering CommitteeThis Guideline has been developed by the appropriate V...

• A. General elements
• B. Specific evaluation studies

VICH GL21（ANTHELMINTICS：POULTRY-GALLUS GALLUS）June 2001 For implementation at Step 7-Draft 1

EFFICACY OF ANTHELMINTICS：SPECIFIC RECOMMENDATIONS FOR POULTRY-GALLUS GALLUSRecommended for Implementation on June 2001 by the VICH Steering CommitteeThis Guideline has been developed by the...

• INTRODUCTION
• A. General Elements
• B. Specific Evaluation Studies

VICH GL24（PHARMACOVIGILANCE：AERS）October 2007 For implementation at Step 7

PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCTS：MANAGEMENT OF ADVERSE EVENT REPORTS（AERs）Adopted at Step 6 of the VICH Process by the VICH Steering Committee on 18 October 2007 for implem...

• 1 Introduction
• 2 Scope
• 3 Definitions
• 4 The Pharmacovigilance Process

VICH GL 29（PHARMACOVIGILANCE）June 2006 For implementation at Step 7-Final

PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCTS-MANAGEMENT OF PERIODIC SUMMARY UPDATE REPORTSRecommended at Step 7 of the VICH Process by the VICH Steering Committee in June 2006 for impl...

• I. INTRODUCTION
• II. SCOPE
• III. DEFINITIONS
• IV. TIMING OF REPORTING
• V. CONTENTS

VICH GL42（PHARMACOVIGILANCE：AERS）June 2010 For implementation at Step 7-Final

PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCTS：DATA ELEMENTS FOR SUBMISSION OF ADVERSE EVENT REPORTS（AERs）Recommended for Implementation at Step 7 of the VICH Process by the VICH Steerin...

VICH GL25（BIOLOGICALS：FORMALDEHYDE）April 2002 For implementation at Step 7-Final TESTING OF RESIDUAL FORMALDEHYDE

Recommended for Implementation on April 2002 by the VICH Steering CommitteeThis Guideline has been developed by the appropriate VICH Expert Working Group and was subject to consultation by t...

• INTRODUCTION
• Ferric Chloride Method
• Appendix
• References

VICH GL26（BIOLOGICALS：MOISTURE）April 2002 For implementation at Step 7-Final

TESTING OF RESIDUAL MOISTURERecommended for Implementation on April 2002 by the VICH Steering CommitteeThis Guideline has been developed by the appropriate VICH Expert Working Group and was ...

• INTRODUCTION
• Residual Moisture Assay

VICH GL34（BIOLOGICALS：MYCOPLASMA）February 2013 For Implementation at Step 7-Final

TESTING FOR THE DETECTION OF MYCOPLASMA CONTAMINATIONAdopted at Step 7 of the VICH Process by the VICH Steering Committee in February 2013 for implementation by 28 February 2014.This Guideli...

• 1 INTRODUCTION
• 2 GUIDELINE FOR TESTING FOR MYCOPLASMA CONTAMINATION
• 3 APPENDICES

VICH GL17（STABILITY 4）June 2000 For implementation at Step 7

STABILITY TESTING OF NEW BIOTECHNOLOGICAL/BIOLOGICAL VETERINARY MEDICINAL PRODUCTSRecommended for Implementation at Step 7 of the VICH Process on 15 June 2000 by the VICH Steering CommitteeT...

• 1 PREAMBLE
• 2 SCOPE OF THE ANNEX
• 3 TERMINOLOGY
• 4 SELECTION OF BATCHES
• 5 STABILITY-INDICATING PROFILE
• 6 STORAGE CONDITIONS
• 7 USAGE CONDITIONS
• 8 TESTING FREQUENCY
• 9 SPECIFICATIONS
• 10 LABELING
• 11 GLOSSARY

VICH GL40（QUALITY）November 2005 For implementation at Step 7

TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW BIOTECHNOLOGICAL/BIOLOGICAL VETERINARY MEDICINAL PRODUCTSRecommended for Adoption at Step 7 of the VICH Process in November 2005 by the VICH S...

• 1 INTRODUCTION
• 2 PRINCIPLES FOR CONSIDERATION IN SETTING SPECIFICATIONS
• 3 JUSTIFICATION OF THE SPECIFICATION
• 4 SPECIFICATIONS
• 5 GLOSSARY
• 6 APPENDICES

VICH GL50（BIOLOGICALS：TABST）May 2017 Revision at Step 9 For Implementation at Step 7-Final

HARMONISATION OF CRITERIA TO WAIVE TARGET ANIMAL BATCH SAFETY TESTING FOR INACTIVATED VACCINES FOR VETERINARY USERevision at Step 9 Adopted at Step 7 of the VICH Process by the VICH Steering...

• 1 INTRODUCTION
• 2 GUIDELINE
• 3 GLOSSARY
• 4 REFERENCES

VICH GL55（BIOLOGICALS：TABST LIVE VACCINES）May 2017 For Implementation at Step 7-Final

HARMONISATION OF CRITERIA TO WAIVE TARGET ANIMAL BATCH SAFETY TESTING FOR LIVE VACCINES FOR VETERINARY USEAdopted at Step 7 of the VICH Process by the VICH Steering Committee in May 2017 for...

• 1 INTRODUCTION
• 2 GUIDELINE
• 3 GLOSSARY
• 4 REFERENCES

VICH GL 41（TARGET ANIMAL SAFETY）-REVERSION TO VIRULENCE July 2007 For implementation at Step 7

TARGET ANIMAL SAFETY：EXAMINATION OF LIVE VETERINARY VACCINES IN TARGET ANIMALS FOR ABSENCE OF REVERSION TO VIRULENCERecommended for Adoption at Step 7 of the VICH Process in July 2007 by the...

• 1 INTRODUCTION
• 2 STUDY DESIGN
• 3 GLOSSARY

VICH GL 44（TARGET ANIMAL SAFETY）-BIOLOGICALS July 2008 For implementation at Step 7

TARGET ANIMAL SAFETY FOR VETERINARY LIVE AND INACTIVATED VACCINESAdopted at Step 7 of the VICH Process by the VICH Steering Committee in July 2008 for implementation in July 2009This Guideli...

• 1 INTRODUCTION
• 2 GUIDELINES
• 3 GLOSSARY