International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
The veterinary analogue of ICH (EU/Japan/US trilateral) — harmonizes technical requirements for veterinary medicines, including GL9 Good Clinical Practice.
WHAT VICH COVERS
VICH — the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products — is the veterinary counterpart to ICH. It brings together the EU, US, and Japan as members, with other regions participating as observers, to harmonise the technical requirements for veterinary medicine registration.
WHERE IT SITS INTERNATIONALLY
VICH deliberately parallels ICH, so practitioners familiar with the ICH Q/S/E structure will recognise the logic — applied to a sector where food-residue safety is an additional axis. That parallel is why veterinary manufacturing rarely needs a separate quality philosophy: the GMP expectations track human medicines closely, and the genuinely distinct work sits in target-animal safety, residue depletion, and withdrawal-period justification.
HOW ITS REQUIREMENTS BITE
Like ICH, VICH neither inspects nor enforces. Its guidelines take effect when regional authorities adopt them — FDA’s Center for Veterinary Medicine, the EU under Regulation (EU) 2019/6, and Japan’s authorities each implement them into their own frameworks.
WHAT VICH PUBLISHES
- 01GL guidelines covering quality, safety, and efficacy for veterinary products
- 02GL3 — stability testing of new veterinary drug substances and medicinal products
- 03GL9 — Good Clinical Practice for veterinary clinical trials
- 04Guidance on target animal safety and residue studies
- 05Guidelines on pharmacovigilance for veterinary medicines
WHAT PRACTITIONERS GET WRONG
- ›VICH guidelines mirror their ICH equivalents in structure — GL3 is the veterinary analogue of ICH Q1A, and reading them side by side is the fastest way in.
- ›Veterinary products add requirements ICH does not address: target animal safety, and residues in food-producing species with the withdrawal periods that follow from them.
- ›Adoption is regional; confirm the status in each market rather than assuming a guideline is in force because it has been published.
- ›EU veterinary requirements were substantially reshaped by Regulation (EU) 2019/6, which replaced the earlier directive-based framework.
- ›A site making both human and veterinary products runs one GMP system but two registration and residue regimes — the quality system converges, the dossier requirements do not.
VICH STANDARDS SPEQ DECODES · 2
DISCIPLINES IN VICH’S REMIT
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New rules, guidance, enforcement, and inspection signals from International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products and its peers worldwide, distilled into the free Weekly GxP Briefing.