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 members, from the observers and from VICH Outreach Forum countries on the topics identified by the VICH Steering Committee in a consultative process.
Step 1 The Steering Committee (SC):
The appropriate EWG elaborates a draft guideline, and submits it to the Secretariat with the signatures of all experts.
The draft guideline is submitted to the SC for approving its release for consultation.
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.
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.
The revised draft guideline is submitted to the SC for approval.
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.
The SC members report to the SC on the implementation of the guidelines in their respective regions.
Monitoring, maintenance and review of guidelines:
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 approximately every 9 months. The location of meetings, which normally last 2 days, alternates between Japan, the EU and the US. All meetings are normally held in English, but participants can bring their own translators.