VICH: Veterinary Product Registration Guidelines & Structure
VICH, or the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, is a trilateral program launched in 1996 by the EU, Japan, and the USA. Its core goal is to harmonize the technical requirements for veterinary product registration dossiers globally, reducing duplication of studies, minimizing animal use, and accelerating product development.
Key Takeaways
VICH harmonizes technical requirements for veterinary medicinal product registration.
The program is trilateral, involving the EU, Japan, and the USA as founding members.
Guidelines are developed through a rigorous 9-step procedure involving public consultation.
VICH aims to reduce study duplication and promotes the 3Rs (Reduce, Refine, Replace).
The Steering Committee makes decisions by consensus and oversees Expert Working Groups.
What is VICH and what is its primary focus?
VICH, the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products, is a trilateral program launched in 1996, triggered by the OIE (now WOAH). Its primary goal is to harmonize the technical requirements necessary for registering veterinary products across major global markets. This focus ensures consistency in the data generation required for the registration dossier, streamlining the approval process internationally and promoting efficiency in the veterinary pharmaceutical industry.
- It operates as a Trilateral Program involving the EU, Japan, and the USA.
- The main goal is Harmonizing Technical Requirements for veterinary product registration.
- Focuses specifically on Data Generation for the Registration Dossier.
- Launched in 1996 following initiation by the OIE (now WOAH).
How is VICH structured and who are its key members?
VICH is governed by a Steering Committee (SC) composed of decision-makers from the founding members (EU, Japan, USA), who operate strictly by consensus to ensure broad agreement. The SC meets annually face-to-face and mid-year online, establishing Expert Working Groups (EWG) to draft technical guidelines. The Secretariat, provided by Health for Animals (a global industry body), supports the SC’s administrative functions. Furthermore, the VICH Forum (VF) was created in 2011 to promote wider international harmonization and awareness among over 25 non-founding countries.
- The Steering Committee (SC) acts as the decision-making body, requiring all decisions by consensus.
- Standing Members attending SC meetings include Australia, New Zealand, Canada, South Africa, and the UK.
- Expert Working Groups (EWG) are established by the SC, focusing on areas like Safety, Quality, and Pharmacovigilance.
- The VICH Forum (VF) facilitates Wider International Harmonization and awareness among non-founding countries.
What are the core objectives of VICH, and what regulatory functions does it avoid?
VICH's core objectives center on developing international technical guidelines covering quality, safety, and efficacy to reduce regulatory duplication and minimize animal use, aligning with the 3Rs principle (Reduce, Refine, Replace). It actively monitors and maintains these guidelines, updating them to reflect scientific developments, and responds proactively to emerging issues like antimicrobial resistance (AMR) and the use of big data. Crucially, VICH does not provide national regulatory guidance, assess generated data, grant marketing authorizations, or establish safety standards like Codex MRLs, leaving those final decisions to national authorities.
- Develop International Technical Guidelines covering Quality, Safety, and Efficacy.
- Reduce Duplication of studies to minimize animal use and lower costs.
- Monitor and Maintain Guidelines, updating them based on scientific developments.
- Foster Wider International Harmonization through the VICH Forum.
- Be Responsive to emerging issues such as AMR, AI, and Big Data.
- VICH does NOT provide National Regulatory Guidance or Grant Marketing Authorizations.
How does VICH develop and implement its technical guidelines?
VICH guidelines follow a rigorous 9-step procedure, beginning when the Steering Committee (SC) approves a topic and appoints an Expert Working Group (EWG). The EWG elaborates the draft, which the SC then approves for public consultation in all member jurisdictions. After the EWG revises the guideline based on public comments, the SC approves the final version, requiring sign-off from founding members. Implementation typically occurs after a 12-month period, followed by systematic review every five years to monitor and maintain relevance and address necessary updates.
- Step 1: SC approves topic and appoints the Expert Working Group (EWG).
- Step 3: SC approves the draft guideline for Public Consultation.
- Step 5: EWG revises the guideline based on received comments.
- Step 6: SC approves the Revised/Final Guideline, requiring sign-off from founding members.
- Step 8: Implementation of the guideline, typically following a 12-month period.
- Step 9: Monitor, Maintain, and Review the guideline, including systematic review every 5 years.
What major achievements has VICH accomplished since its inception?
Since its launch, VICH has successfully developed over 60 guidelines covering pharmaceuticals, biologicals, and pharmacovigilance, with 22 guidelines already revised to maintain scientific relevance. These standards are implemented across the six major founding markets and are increasingly adopted globally, demonstrating the success of the unique regulator-industry collaboration model. VICH’s commitment to consensus decision-making and the 3Rs (Reduce, Refine, Replace) accelerates product development timelines while ensuring high standards of veterinary medicine and regulatory compliance worldwide.
- Developed over 60 Guidelines across Pharmaceuticals, Biologicals, and Pharmacovigilance.
- 22 Guidelines have been revised to date.
- Implemented in 6 major markets with increasing global use.
- Operates via Consensus decision-making among founding members.
- Represents a Unique Regulator-Industry collaboration model.
- Demonstrates Commitment to the 3Rs (Reduce, Refine, Replace) in animal testing.
What is VICH Guideline 9 (GL9) and why has it resisted revision?
VICH Guideline 9 (GL9) establishes Good Clinical Practices (GCP) for veterinary studies, with its concept paper initiated in 1997 and final adoption occurring in June 2000. Despite revision proposals in 2008 and 2022, the Steering Committee concluded that no major revision was needed. This decision was based on the guideline functioning effectively, industry standard operating procedures (SOPs) being well-established, and a fear of the 'Pandora’s box' risk associated with reopening the mandate. Instead of formal revision, VICH prefers clarification through workshops to address minor issues.
- Concept Paper was initiated in January 1997, based on existing EU guidance.
- SC Approval and Adoption of GL9 occurred in June 2000.
- Implementation began in July 2001, taking approximately three years.
- Revision Proposals in 2008 and 2022 concluded that No Revision was Needed.
- Reasons for avoiding revision include established Industry SOPs and fear of 'Pandora’s box' risk.
- VICH prefers Clarification through workshops over formal revision.
Frequently Asked Questions
Which countries form the original trilateral program of VICH?
The original trilateral program of VICH consists of the three founding members: the European Union (EU), Japan, and the United States of America (USA). These members hold decision-making power on the Steering Committee.
What is the main purpose of the VICH Forum (VF)?
The VICH Forum, created in 2011, aims to promote wider international harmonization and awareness of VICH guidelines. It includes over 25 member countries from Africa, Asia, and the Americas, often co-organized with WOAH.
How often are VICH guidelines systematically reviewed?
VICH guidelines are subject to systematic review every five years as part of the monitoring and maintenance process (Step 9). This ensures they remain current and reflect scientific and technical developments.
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