Table of Contents

VICH Updates
VICH Guidance Docs
VICH FR Notices

International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), is a trilateral (EU-Japan-USA) program aimed at harmonizing technical requirements for veterinary product registration. Its full title is the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products. VICH was officially launched in April 1996.

• VICH

• VICH1 - First Conference on International Harmonisation of Veterinary Medical Products - Steering Committee Press Release | doc | | htm |

• VICH2 - Summary of VICH2 Proceedings, October 12, 2002 | pdf | | doc |

• VICH3 - Third Conference on International Harmonisation of Veterinary Medicinal Products, Washington, DC, USA, May 25-27, 2005

CVM Updates on VICH

• Spanish Translations of Three Guidance for Industry Documents Related to VICH Posted on the CVM Website, November 29, 2006

• Draft VICH Guidance Available for Review and Comment, September 4, 2002

• Guidance on Equine, Porcine, and Canine Anthelmintic Effectiveness Available, July 2, 2002

• Guidance on Feline and Poultry (Gallus Gallus) Anthelmintic Effectiveness Available, June 25, 2002

• Draft and Final VICH Guidance Documents Available, October 27, 1999

• FDA Requests Comments on EIA Draft Guidance Document, September 30, 1999

• Final Guidance Published on Validation of Analytical Procedures: Methodology, August 11, 1999

• FDA Requests Comments on Good Clinical Practices Guidance Document, August 11, 1999

• Final Guidance Published on Validation of Analytical Procedures, August 3, 1999

CVM Guidance Documents on VICH

CVM FR Notices on VICH

• Docket No. 2006D-0139, CVM 200790.  International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision); Availability.  Pages  65751-65752 [FR Doc. E7-22900 ] November 23, 2007 | html | | pdf |

• Docket No. 2002D-0005, CVM00718.  International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Revised Draft Guidance for Industry on "Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms,'' VICH GL30; Request for Comments; Availability. Pages  34261-34262 [FR Doc. E7-11996]  | html | | pdf | Comments due July 23, 2007

• Docket No. 2007D-0166, CVM 2006120.  International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Target Animal Safety for Veterinary Pharmaceutical Products, VICH GL43, Request for Comments; Availability.  Pages  28058-28059 [FR Doc. E7-09592]  | html | | pdf | Comments due June 14, 2007

• Docket No. 2005D-0199, CVM 200484. International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH): Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances; Availability. Pages 34625-34626, June 15, 2006 [FR Doc. E6-9327-10624] | html | | pdf |

• Docket No. 2005D-0200, CVM 200485. International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Specifications: Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products;   Availability. Pages 30763-30764 June 15, 2006 [FR Doc. 05-10625] | html | | pdf |

• Docket No. 2006D-0170, CVM20061.  International Coopeation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products; Data Elements for Submission of Adverse Event Reports (VICH GL42); Requests for Comments; Availability.  Pages 25845-25846 [FR Doc. E6-6601]  May 2, 2006 | htm | | pdf |

• Docket No. 2000D-1632, CVM 200590.  Internation Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance for Industry on Pharmacovigilance fo Veterinary Medicinal Products; Management of Adverse Event Reports; Request for Comments; Availability.  Pages 25846-25848 [FR Doc. E6-6602] May 2, 2006 |htm| | pdf |

• Docket No.  2004D-0156, CVM 2004113. International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Final Guidance for Industry on Environmental Impact Assessments for Veterinary Medicinal Products--Phase II; Availability. Pages 1434-1435 [FR Doc. E6-00039 ] January 9, 2006 | htm | | pdf |

• Docket No. 1999D-2145, CVM 200789. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Medicinal Products (Revised) (VICH GL11(R)); Availability. Pages 65752-65753 [FR Doc. E7-22901]  November 23, 2007 | htm | | pdf | 

• Docket No. 1999D-2215, CVM 200788. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Revised Guidance for Industry on Impurities in New Veterinary Drug Substances (Revision); (VICH GL10(R)); Availability. Pages 65753-65754 [FR Doc. E7-22902] November 23, 2007 | htm | | pdf |

• Docket No. 2003D-0474, CVM 200455.  International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Establish a Microbiological ADI (VICH GL-36); Availability.  Pages  7278-7279 February 11, 2005 [FR Doc. 05-02643] | htm | |  pdf |

• Docket No. 2003D-0466, CVM 200457. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity Testing (VICH GL-37); Availability. Pages 6449-6450 [FR Doc. 05-02266] February 7, 2005 | htm | | pdf |

• Docket No. 2001D-0357, CVM 2003134.  International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products; Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing; Availability.  Pages  29740-29742 [FR Doc. 04-11781]  May 25, 2004 | htm | | pdf |

• Docket No. 2002D-0326, CVM 200367.  International Cooperation on Harmonization of Technical Requirements for Approval of Veterinary Medicinal Products; Final Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: General Approach to Testing, GL33; Availability.  Pages  28933-28934 [FR Doc. 04-11254] May 19, 2004 | htm | | pdf |

• Docket No. 2003D-0051, CVM 20042.  International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products; Guidance for Industry on Pre-Approval Information for Registration of New Veterinary Medicinal Products for Food-Producing Animals With Respect to Antimicrobial Resistance (VICH GL27); Availability.  Pages  23795-23796 [FR Doc. 04-9836] April 30, 2004 | htm | | pdf |

• Docket No. 2002D-0369, CVM 2000366.  International Cooperation on Harmonization of Technical Requirements for Approval of Veterinary Medicinal Products; Guidance for Industry on Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Developmental Toxicity Testing; Availability.  Pages 13306-13307 [FR Doc.04-6252 ]  March 22, 2004  | htm | | pdf |

• Docket No. 2002D-0368, CVM 200365. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products; Guidance for Industry on “Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing” (VICH GL31); Availability. Pages 64353-64354 [FR Doc. 03-28371] November 13, 2003 | htm | pdf |

• Docket No. 00D-1532, CVM 200164. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidances for Industry on Effectiveness of Anthelmintics: Specific Recommendations for Equine (VICH GL15), Effectiveness of Anthelmintics: Specific Recommendations for Porcine (VICH GL16), and Effectiveness of Anthelmintics: Specific Recommendations for Canine (VICH GL19); Availability. Pages 43332--43333 [FR Doc. 02-16292] June 27, 2002 | htm | | pdf |

• Docket No. 99D-4071, CVM 200038. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry on “Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients” (VICH GL18); Availability.
  Pages 28182--28183 [FR Doc. 01-12770] May 22, 2001 | htm | | pdf |

• Docket No. 99D-2406, CVM 20009. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry entitled Good Clinical Practice (VICH GL9); Availability. Pages 26868-26869 [FR Doc. 01-12092] May 15, 2001 | htm | | pdf |

• Docket No. 99D-4070, CVM 200037. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Final Guidance for Industry Entitled “Stability Testing of New Biotechnological/Biological Veterinary Medicinal Products” (VICH GL17); Availability. Pages 19177-19178 [FR Doc. 01-09259 ] April 13, 2001 | htm | | pdf |

• Docket No. 99D-2248, CVM 20008. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Final Guidances entitled “Effectiveness of Anthelmintics: General Recommendations” (VICH GL7), “Effectiveness of Anthelmintics: Specific Recommendations for Bovine” (VICH GL12), “Effectiveness of Anthelmintics: Specific Recommendations for Ovine” (VICH GL13), and “Effectiveness of Anthelmintics: Specific Recommendations for Caprine” (VICH GL14); Availability. Pages 18257-15259 [FR Doc. 01-08452] April 6, 2001 | txt | | pdf |

• Docket No. 99D-2975, CVM 98154. International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); VICH GL6 Draft Guidance on "Environmental Impact Assessments (EIA's) for Veterinary Medicinal Products (VMP's)-Phase I;" Availability; Request for Comments.- September 17, 1999| txt | | pdf |

• Docket No. 98D-0566, CVM 9964. International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Final Guidances entitled "Stability Testing of New Veterinary Drug Substances and Medicinal Products" (VICH GL3); "Stability Testing of New Veterinary Dosage Forms'' (VICH GL4); "Stability Testing: Photostability Testing of New Veterinary Drug Substances and Medicinal Products'' (VICH GL5); Availability. October 12, 1999 | txt | | pdf |

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