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).
What this does not cover
stated in the document's own scope- Covers clinical (in-animal) studies of veterinary products; nonclinical laboratory safety studies follow GLP (OECD GLP Principles / 21 CFR Part 58).
- Is a harmonised guideline, not law by itself; the binding requirement is the regional implementation, such as FDA GFI #85.
- Addresses veterinary clinical studies; the equivalent human-medicine standard is ICH E6 (GCP).
Always verify against the current published text before relying on it for a submission or inspection.
Overview
VICH GL9 is the harmonised Good Clinical Practice standard for veterinary medicines — the veterinary analogue of ICH E6. It sets the expectations for designing, conducting, monitoring, recording, and reporting clinical studies that support the safety and efficacy of veterinary medicinal products. It defines the responsibilities of the sponsor, monitor, and investigator, the role of the study protocol, the handling of the investigational veterinary product, the requirements for records and data, animal welfare and owner consent considerations, and the reporting of results — so that a study’s conduct and data can be trusted and reconstructed. Its purpose is reliable, ethically conducted evidence for veterinary product authorisation.
Scope & applicability
Clinical studies conducted to support marketing authorisation of veterinary medicinal products in VICH regions.
Legal basis & how it acquires force
GL9 is a guideline of VICH — the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products. Like an ICH guideline it is not itself law; it takes effect when each VICH region implements it. In the United States it is adopted by FDA’s Center for Veterinary Medicine as Guidance for Industry #85; in the European Union it is implemented through the EMA veterinary framework; and Japan gives it effect through its own authority. A sponsor therefore complies with the regional instrument, with GL9 supplying the harmonised technical standard behind it.
Document structure
| Part | Covers |
|---|---|
| Scope and definitions | The clinical studies covered and the key GCP terms used throughout |
| Sponsor and monitor responsibilities | Study management, monitoring, and quality of the trial by the sponsor and its monitor |
| Investigator responsibilities | The investigator’s duties for conduct, records, and animal and site management |
| Study protocol and conduct | The protocol content and the conduct of the veterinary clinical study |
| Investigational product and records | Handling and accountability of the investigational veterinary product and study records and data |
| Reporting | The study report and the reporting of results supporting the marketing application |
Key requirements
- 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
- Report results completely and accurately
Implementation tips
- Map GL9 onto your ICH E6 GCP SOPs — the structure is deliberately parallel
- Treat owner consent and animal welfare documentation as inspection-critical
- Keep raw-data traceability tight; result credibility rests on it
Revision notes
Issued by VICH in 2000 (effective 2001); implemented in the US as FDA Guidance for Industry #85.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
GL9 is deliberately modelled on ICH E6, the human-medicine Good Clinical Practice guideline, adapted for veterinary studies and animal-welfare considerations. It is implemented across the VICH regions — the US (FDA CVM, GFI #85), the EU (EMA), and Japan — with other countries participating as observers, so a study designed to GL9 meets a common standard recognised across those regions. It sits within the wider VICH family of veterinary technical guidelines alongside the VICH stability and safety guidelines.
VICH GL9: frequently asked questions
Quick answers to common questions about VICH GL9.
What is VICH GL9 the veterinary equivalent of?
It is the veterinary Good Clinical Practice standard — the VICH analogue of ICH E6 (GCP) for human medicines — adapted for veterinary clinical studies and animal-welfare considerations.
How is VICH GL9 implemented in the United States?
FDA’s Center for Veterinary Medicine adopts it as Guidance for Industry #85. The EU implements it through the EMA veterinary framework and Japan through its own authority, so the three VICH regions share the standard.
What does VICH GL9 govern?
The design, conduct, monitoring, recording, and reporting of clinical studies that support the safety and efficacy of veterinary medicinal products, together with the responsibilities of sponsor, monitor, and investigator.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.