What is VICH?

The Veterinary International Conference on Harmonization, or VICH, is a program that aims to harmonize the technical requirements for the registration of veterinary products. It was officially launched in 1996, despite harmonization processes beginning as early as 1983. Currently, 3 regions constitute the principal VICH parties (and are the founding members) which are the USA, the European Union (EU), and Japan. There are 6 parties, from these 3 regions, that form the steering committee & members of VICH:

USA

• US FDA - Center for Veterinary Medicine (CVM) and US Department of
• Agriculture- Center for Veterinary Biologics (USDA/CVB)
• US Animal Health Institute (AHI) representing industry

EU

• European Commission & EMA
• Animal health Europe representing industry

Japan

• Ministry of Agriculture, Forest and Fisheries (JMAFF)
• The Japanese Veterinary Products Association (JVPA) represents industry

Various authorities and organizations form the standing members of the VICH process, and they belong to Australia, New Zealand, Canada, South Africa, the United Kingdom, and Switzerland.

What is the significance of VICH in the regulatory landscape?

VICH’s objectives are similar to those of ICH’s and ensure the following:

• Harmonized standards for veterinary medicinal products
• Foundation for global harmonization of registration requirements
• Continuous review and updating of VICH guidelines
• Consistency in data requirement interpretation
• Collaborative dialogue for addressing emerging regulatory challenges

The steering committee meets every year either in the US, EU, or Japan to discuss further developments related to the guidelines. They follow a 9-step procedure which is briefly outlined below.

The steering committee meets every year either in the US, EU, or Japan to discuss further developments related to the guidelines. They follow a 9-step procedure which is briefly outlined below.

• The steering committee selects a priority item from a concept paper, assigns it to an EWG, and appoints a topic leader/chairperson. This person is given a clear mandate to draft the guidelines, ensuring they have the appropriate skills to achieve the desired objectives.
• The EWG prepares a draft guideline and submits it to the Secretariat, with signatures from all participating experts.
• The draft guideline is submitted to the steering committee for approval to be released for consultation.
• Once the steering committee has adopted it, the draft guideline is published for consultation by the VICH secretariat and regulatory authorities of VICH member countries, usually for 6 months. Regulatory coordinators should notify the VICH secretariat of any delays in their respective regions’ consultation process.
• The EWG reviews all comments received and prepares a revised draft, which is submitted to the Secretariat with signatures from all experts. The signatures of industry experts are distinguished from those of regulatory authority representatives, with the leader of the topic being the regulatory authority representative.
• The updated draft is presented to the steering committee for approval.
• Once the steering committee has approved, the final guideline and suggested implementation data are distributed to the regulatory authorities represented on the steering committee.
• The steering committee members share updates on the implementation of the guidelines in their respective regions.
• Guidelines should be reviewed at least every 5 years after adoption so that new developments can be incorporated, with the VICH secretariat notifying the steering committee when this milestone is reached. Any member of the steering committee can propose a review at any time, submitting a concept paper with rationale and background before the next steering committee meeting. If the committee agrees to a review, they will assign the task to the relevant EWG or topic leader. The steering committee will then decide the appropriate stage to begin the revision process.

DDReg’s Capabilities

DDReg provides its customers with comprehensive support in navigating VICH guidelines to ensure complete compliance. The team brings a thorough understanding and experience of working with global regulatory frameworks to help its customers align their processes with global standards. This ensures timely approvals, risk mitigation, and smooth product lifecycle management, ultimately enhancing regulatory success globally.