Veterinary International Conference on Harmonization (VICH) Guidance Documents
The International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) is a trilateral program officially launched in April 1996. The program aims to harmonize technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives. In support of wider international harmonization of regulatory requirements, VICH guidelines are also available for use by other countries. The collective work also helps to reduce animal testing, facilitate trade, and ensure veterinary product safety and consumer confidence in the regulated products. For more information, see https://www.vichsec.org/en/. A list of VICH guidance documents can be found below.
- CVM GFI #63 - VICH GL1 - Validation of Analytical Procedures: Definition and Terminology
- CVM GFI #64 - VICH GL2 - Validation of Analytical Procedures: Methodology
- CVM GFI #73 - VICH GL3(R) - Stability Testing of New Veterinary Drug Substances and Medicinal Products
- CVM GFI #74 - VICH GL4 - Stability Testing of New Veterinary Dosage Forms
- CVM GFI #75 - VICH GL5 - Stability Testing-Photostability Testing of New Veterinary Drug Substances and Medicinal Products
- CVM GFI #89 - VICH GL6 - EIA's for Veterinary Medicinal Products - Phase I
- CVM GFI #90 (VICH GL7) Effectiveness of Anthelmintics: General Recommendations
- CVM GFI #91 - VICH GL8 - Stability Testing for Medicated Premixes
- CVM GFI #85 - VICH GL9 - Good Clinical Practices
- CVM GFI #92 - VICH GL10(R) - Impurities In New Veterinary Drug Substances
- CVM GFI #93 - VICH GL11(R) - Impurities in New Veterinary Medicinal Products
- CVM GFI #95 (VICH GL12) Effectiveness of Anthelmintics: Specific Recommendations for Bovines
- CVM GFI #96 (VICH GL13) Effectiveness of Anthelmintics: Specific Recommendations for Ovines
- CVM GFI #97 (VICH GL14) Effectiveness of Anthelmintics: Specific Recommendations for Caprines
- CVM GFI #109 (VICH GL15) Effectiveness of Anthelmintics: Specific Recommendations for Equines
- CVM GFI #110 (VICH GL16) Effectiveness of Anthelmintics: Specific Recommendations for Porcines
- CVM GFI #99 - VICH GL17 - Testing of New Biotechnological/Biological Products
- CVM GFI #100 - VICH GL18 (R2) - Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)
- CVM GFI #111 (VICH GL19) Effectiveness of Anthelmintics: Specific Recommendations for Canines
- CVM GFI #113 (VICH GL20) Effectiveness of Anthelmintics: Specific Recommendations for Felines
- CVM GFI #114 (VICH GL21) Effectiveness of Anthelmintics: Specific Recommendations for Chickens Gallus gallus
- CVM GFI #115 (VICH GL22) Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Reproduction Toxicity Testing (Revision 1)
- CVM GFI #116 - VICH GL23 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing
- CVM GFI #117 - VICH GL24 - Management of Adverse Event Reports (AER's)
- CVM GFI #144 VICH GL27: Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals with Respect to Antimicrobial Resistance
- CVM GFI #141 - VICH GL28 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing,
- CVM GFI #142 - VICH GL29 - Pharmacovigilance of Veterinary Medicinal Products: Management of Periodic Summary Update Reports (PSUs)
- CVM GFI #143 - VICH GL30 - Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms
- CVM GFI #147 - VICH GL31 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food Repeat-Dose (90 Day) Toxicity Testing
- CVM GFI #148 - VICH GL32 - Developmental Toxicity Testing
- CVM GFI #149 - VICH GL33 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing
- CVM GFI #214 - VICH GL35 - Electronic Standards for Transfer of Data
- CVM GFI #159 - VICH GL36 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI
- CVM GFI #160 - VICH GL37- Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing
- CVM GFI #166 - VICH GL38 - Environmental Impact Assessment's (EIA's) for Veterinary Medicinal Products (VMP's) - Phase II
- CVM GFI #176 - VICH GL39 - Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances
- CVM GFI #177 - VICH GL40 - Test Procedures/Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Product
- CVM GFI #185 - VICH GL43 -Target Animal Safety for Veterinary Pharmaceutical Products
- CVM GFI #198 - VICH GL45 - Bracketing and Matrixing Designs For Stability Testing of New Veterinary Drug Substances and Medicinal Products
- CVM GFI #205 - VICH GL46 - 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 Residues (MRK)
- CVM GFI #206 - VICH GL47 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies In Laboratory Animals
- CVM GFI #207 - VICH GL48 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies to Establish Product Withdrawal Periods
- CVM GFI #208 - VICH GL49 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies
- CVM GFI #219 - VICH GL51 - Statistical Evaluation of Stability Data
- CVM GFI #224 - VICH GL52 - Bioequivalence: Blood Level Bioequivalence Study
- Supplement to CVM GFI #224 - VICH GL52 - Supplemental Examples For Illustrating Statistical Concepts Described in the VICH In Vivo Bioequivalence Draft Guidance GL52
- CVM GFI #225 - VICH GL53 - Electronic Exchange of Documents: File Format Recommendations
- CVM GFI #232 - VICH GL54 - Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish an Acute Reference Dose (ARfD)
- CVM GFI #243 - VICH GL56 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods
- CVM GFI #257 - VICH GL57 - Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Species: Marker Residue Depletion Studies to Establish Product Withdrawal Periods in Aquatic Species
- CVM GFI #259 - VICH GL58 - Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
- CVM GFI #286 (VICH GL60) - Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products
- CVM GFI #290 (VICH GL61) – Pharmaceutical Development