VICH Process
Process to develop harmonised guidelines
The VICH guidelines on the technical requirements for marketing authorisation applications for veterinary medicinal products are developed by expert working groups comprising experts from the different VICH Founding and Standing members and from VICH Forum countries on the topics identified by the VICH Steering Committee in a consultative process.
The driver: The Steering Committee
The VICH Steering Committee is the driver of the process for the development of harmonised technical requirements, i.e. the development of VICH guidelines.
The Steering Committee is the body within VICH that is empowered to take decisions such as selecting topics, releasing draft guidelines for consultation, and adopting final guidelines for implementation in the three regions. The VICH Steering Committee currently meets once a year. The location of meetings, which last 3 to 4 days, alternates between Japan, the EU and the US. All meetings are normally held in English, but participants can bring their own translators.
The 9-Step Procedure
Step 1 The Steering Committee (SC):
- defines a priority item from a detailed concept paper prepared by one of its members;
- designates the topic to or establishes an EWG, as appropriate, and appoints an EWG topic leader and/or chairperson. The EWG chair/topic leader in charge of drafting the guideline is given a clear mandate to do the expected work;
- ensures that each topic leader has the required competence and interpersonal skills to lead an EWG and achieve its objectives.
Step 2
The appropriate EWG elaborates a draft guideline, and submits it to the Secretariat with the signatures of all experts.
Step 3
The draft guideline is submitted to the SC for approving its release for consultation.
Step 4
Once adopted by the SC, the draft guideline is published for consultation by the VICH secretariat and by the regulatory authorities of all VICH members, applying an appropriate consultation period (normally 6 months). The regulatory coordinators should inform the VICH secretariat if the consultation process in their region is delayed.
Step 5
The comments received are directed to the EWG for consideration. At this step, the topic leader must be a representative of a regulatory authority. The EWG prepares a revised draft and submits it to the Secretariat with the signature of all experts. The signatures of industry experts are clearly separated from those of experts representing regulatory authorities.
Step 6
The revised draft guideline is submitted to the SC for approval.
Step 7
Once approved by the SC, the final guideline and a proposed date for its implementation are circulated to the regulatory authorities represented in the SC.
Step 8
The SC members report to the SC on the implementation of the guidelines in their respective regions.
Step 9
Monitoring, maintenance and review of guidelines:
The SC decides on the appropriate step at which the revision procedure shall start.
The necessity to review adopted guidelines should be determined, at least every 5 years, following the implementation in order to take account of new developments. The secretariat will notify the SC of the guidelines that have reached this five years milestone.
Any SC member may propose to review an adopted guideline at any time and inform the VICH secretariat in due time prior the next SC meeting. Such proposal should be accompanied by an abbreviated concept paper detailing the rationale and the background to the proposed review.
If the SC acknowledges the need for a review of the guideline, the SC will designate the appropriate EWG or a topic leader as the reviewer.
The Organisational Charter
Download the Organisational Charter document here (VICH/96/002, revision 17, June 2023, Final)
VICH Priorities Phase 5: 2021-2025 (VICH/19/017-Final Nov 2020)
Download the VICH Priorities Phase 5: 2021-2025 document here