Good Clinical Practice (Veterinary)
The veterinary Good Clinical Practice standard from VICH (the veterinary analogue of ICH). GL9 sets the design, conduct, monitoring, recording, and reporting expectations for clinical studies that support the safety and efficacy of veterinary medicinal products, adopted by the EU, Japan, and the US (FDA GFI #85).
Clinical studies conducted to support marketing authorisation of veterinary medicinal products in VICH regions.
- 01Design and conduct studies under a controlled protocol
- 02Define investigator responsibilities and sponsor oversight
- 03Obtain owner/keeper consent and safeguard animal welfare
- 04Capture raw data contemporaneously with full traceability
- 05Report results completely and accurately
Issued by VICH in 2000 (effective 2001); implemented in the US as FDA Guidance for Industry #85.
VICH GL9: frequently asked questions
Quick answers to common questions about VICH GL9.
What is VICH GL9?
VICH GL9 — Good Clinical Practice (Veterinary) — is a guideline issued by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. The veterinary Good Clinical Practice standard from VICH (the veterinary analogue of ICH). GL9 sets the design, conduct, monitoring, recording, and reporting expectations for clinical studies that support the safety and efficacy of veterinary medicinal products, adopted by the EU, Japan, and the US (FDA GFI #85).
Who does VICH GL9 apply to?
Clinical studies conducted to support marketing authorisation of veterinary medicinal products in VICH regions.
What are the key requirements of VICH GL9?
VICH GL9 requires, among other things: Design and conduct studies under a controlled protocol; Define investigator responsibilities and sponsor oversight; Obtain owner/keeper consent and safeguard animal welfare; Capture raw data contemporaneously with full traceability.
When was VICH GL9 last updated?
The current version of VICH GL9 dates from July 2000. Issued by VICH in 2000 (effective 2001); implemented in the US as FDA Guidance for Industry #85.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When VICH GL9 — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.