Official texts of final guidelines

• Validation of analytical procedures : Definition and Terminology
  VICH GL1 (Validation definitions) Implemented in October 1999
• Validation of analytical procedures : Methodology
  VICH GL2 (Validation methods) Implemented in October 1999
• Stability testing of new drugs substances and products
  VICH GL3 (Stability drugs) Implemented in May 2000
• Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision)
  VICH GL3 (Quality) – For implementation in January 2008
• Stability Testing :Requirements for New Dosage Forms
  Annex to the VICH guidelines on Stability Testing for New Drugs and Products
  VICH GL4 (Stability products) Implemented in May 2000
• Stability Testing :Photostability Testing of New Drug Substances and Products
  VICH GL5 (Photostability) Implemented in May 2000
• Environmental Impact Assessment (EIAs) for veterinary medicinal products (VMPs) - Phase 1
  VICH GL6 (Ecotoxicity - Phase 1) June 2000 - Implemented in July 2001
• Efficacy of Anthelmintics: General Requirements
  VICH GL7 (Anthelmintics General) November 2000 - Implemented in June 2001
• Stability Testing for Medicated Premixes
  VICH GL8 (Stability premixes) November 1999 - Implemented in June 2001
• Good Clinical Practices
  VICH GL9 (GCP) June 2000 - Implemented in July 2001
• Impurities in New Drug Subtances
  VICH GL10 (Impurities New Subtances) November 1999 - Implemented in June 2001
• Impurities in New Veterinary Drug Substances (Revision)
  VICH GL10 10 (R) (Quality) – For implementation in January 2008  
• Impurities in New Veterinary Medicinal products
  VICH GL11 (Impurities New VMPs) November 1999 - Implemented in June 2001
• Impurities in New Veterinary Medicinal Products (Revision)
  VICH GL11 (R) (Quality) – For implementation in January 2008
• Efficacy of Anthelmintics : Specific Recommendations for Bovines
  VICH GL12 (Anthelmintics : Bovines) November 1999 - Implemented in June 2001
• Efficacy of Anthelmintics : Specific Recommendations for Ovines
  VICH GL13 (Anthelmintics : Ovines) November 1999 - Implemented in June 2001
• Efficacy of Anthelmintics : Specific Recommendations for Caprines
  VICH GL14 (Anthelmintics : Caprines) November 1999 - Implemented in June 2001
• Efficacy of Anthelmintics : Specific Recommendations for Equine
  VICH GL15 (Anthelmintics : Equine) June 2001 - Implemented in July 2002
• Efficacy of Anthelmintics : Specific Recommendations for Swine
  VICH GL16 (Anthelmintics : Swine) June 2001 - Implemented in July 2002
• Stability testing of new biotechnological/biological veterinary medicinal products
  VICH GL17 (Stability: biotechnologicals/biologicals) June 2000 - Implemented in July 2001
• Impurities: Residual Solvents in new veterinary medicinal products, active substances and excipients
  VICH GL18 (Impurities: Residual Solvents) June 2000 - Implemented in in July 2001
• Efficacy of Anthelmintics : Specific Recommendations for Canine
  VICH GL19 (Anthelmintics : Canine) June 2001 - Implemented in July 2002
• Efficacy of Anthelmintics: Specific Recommendations for Feline
  VICH GL20 (Anthelmintics: Feline) June 2001 - Implemented in July 2002
• Efficacy of Anthelmintics: Specific Recommendations for Poultry
  VICH GL21 (Anthelmintics: Poultry) June 2001 - Implemented in July 2002
• Studies to evaluate the safety of residues of veterinary drugs in human food: Reproduction Testing
  VICH GL22 (Safety: Reproduction) June 2001 - For implementation by 1 August 2002 - Revision 1 of May 2004
• Studies to evaluate the safety of residues of veterinary drugs in human food: Genotoxicity Testing
  VICH GL23 (Safety: Genotoxicity) June 2001 - For implementation by 1 August 2002 - Revision 1 of May 2004
• Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs)
  VICH GL24 (Pharmacovigilance) - October 2007 - For implementation to be determined Pending adoption of GL 30 and GL 35 - Regulatory Authorities may consider implementation at an earlier stage as appropriate
• Testing of residual formaldehyde
  VICH GL25 (Biologicals: Formaldehyde) November 2000 - Implemented in May 2003
• Testing of residual moisture
  VICH GL26 (Biologicals: Moisture) November 2000 - Implemented in May 2003
• Pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance
  VICH GL27 (Antimicrobial resistance: pre-approval) - Implemented in December 2004
• Studies to evaluate the safety of residues of veterinary drug in human food: carcinogenicity testing
  VICH GL28 (Safety: Carcinogenicity) October 2002 - Implemented in October 2003
• Pharmacovigilance of Veterinary Medicinal Products - Management of Periodic Summary Update Reports
  GL29 (Pharmacovigilance) June 2006 - For implementation by June 2007
  
• Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose (90 days) Toxicity Testing
  VICH GL31 (Safety: Repeat-dose Toxicity) October 2002 - For implementation in October 2003 - Revision 1 of May 2004
• Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental Toxicity Testing
  VICH GL32 (Safety: Developmental Toxicity) October 2002 - For implementation in October 2003 (Except EU: later date) - Revision 1 of May 2004
• Studies to evaluate the safety of residues of veterinary drugs in human food: General Approach to Testing
  VICH GL33 (Safety: General Approach) October 2002 - For implementation in October 2003 - Revision 1 of May 2004
• Studies to evaluate the safety of  residues of veterinary drugs in human food: General approach to establish a  microbiological ADI
  VICH GL36 (Safety: General Approach) May 2004 - Implemented in May 2005   
• Studies to evaluate the safety of  residues of veterinary drugs in human food: Repeat-dose (chronic) toxicity  testing
  VICH  GL37 (Safety: Repeat-dose chronic toxicity) May 2004 - Implemented in May 2005
• Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products (VMPs) - Phase II
  VICH GL38 (Ecotoxicity Phase II) October 2004 - Implemented in October 2005
• Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances + Decision Trees
  VICH GL39 (Quality) November 2005 - Implemented in November 2006
• Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products
  VICH GL40 (Quality) November 2005 - Implemented in November 2006
  
• Target Animal Safety - Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence - Annexes
  VICH GL41 - July 2007 - For implementation in July 2008
• Pharmacovigilance of Veterinary Medicinal Products - Data Elements for Submission of Adverse Event Reports
  VICH GL42 (Pharmacovigilance) - October 2007 - For implementation to be determined Pending adoption of GL 30 and GL 35
• Target Animal Safety for Pharmaceuticals
  VICH GL43 (TAS Pharmaceuticals) – July 2008 - For implementation in July 2009
• Target Animal Safety for Veterinary Live and Inactivated Vaccines
  VICH GL44 (TAS Biologicals) - July 2008 - For implementation in July 2009