Activities in VICH
- 1 What is VICH?
- 2 Flow of creating guidelines
- 3 Active EWG list
- 4 Conference history of VICH related international conference
- 5 Recent Activity
1 What is VICH?
The International Cooperation on Harmonization of Technical Requirements for Veterinary Medicinal Products (VICH) was organized in 1996, consisting of regulatory authorities of the three regions of Japan/United States/EU under the OIE umbrella and animal health industry representatives. It has made efforts at the rapid supply of veterinary medicinal products (VMPs) with fair pricing to clinicians by reducing the cost of development and facilitating review by regulatory authorities through the shared usage of internationally harmonized guidelines.
The guidelines for technical documentation for approval of VMPs and post-approval monitoring of VMPs have been developed by VICH.
NVAL has involved its staff in the Steering Committee (SC) and Expert Working Group (EWG) members or advisers for the development of these guidelines. Besides, NVAL has conducted comparison studies between assays in Japan and assays adopted by the United States/EU and has collected information of the specific animal species of Japan.
VICH members
regulatory authorities
animal health industry representatives
Japan
MAFF
Japan veterinary products association
United States
US FDA – Center for Veterinary Medicine, USDA – Center for Veterinary Biologics
US Animal Health Institute
EU
European Commission, European Medicines Agency
IFAH-EUROPE
Representatives of the OIE have participated in the SC meeting as associate members and representatives of Canada, Australia, New Zealand and the South African Republic have participated as observers. (Secretariat of VICH: Health for Animals)
2 Flow of creating guidelines
- Step1:The Steering Committee (SC) decided to consider. Establish an Expert Working Group (EWG) as necessary and provide work instructions
- Step2:EWG creates draft guideline (GL)
- Step3:SC approves to submit the proposed GL submitted by EWG to consultation
- Step4:Discussed at the relevant agencies the GL draft of the EWG approved by the SC
- (Implementation of public consultation)
- Step5:EWG considers opinions by consultation and creates a modified GL draft
- Step6:SC approves implementation of modified GL draft submitted by EWG
- Step7:Send the GL to the regulatory authorities of each country with the enforcement date
- Step8:Implementation of the GL in each region
tation
- Step9:Review of the GL (monitoring and maintenance)
3 Active EWG list
- Quality EWG (Chair; Japan/MAFF)
- Electronic Standards Implementation – Pharmacovigilance (Chair; US/FDA)
- Biologicals Quality Monitoring (Chair; Japan/MAFF)
- Metabolism and Residue Kinetics EWG (Chair; EU)
- Target Animal Safety EWG (Chair; US/FDA)
- Biologicals Quality Monitoring EWG (Chair; US/FDA)
- Efficacy (Anthelmintics) EWG (Chair; US/FDA)
4 Conference history of VICH related international conference
The VICH public Conference
Date
Venue
Sponsorship
Same period holding
1st
November, 1999
Brussels
EU
6th SC meeting
2nd
October, 2002
Tokyo
Japan
11th SC meeting
3rd
May, 2005
Washington D.C.
U.S.
16th SC meeting
4th
June, 2010
Paris
EU
24th SC meeting
5th
October, 2015
Tokyo
Japan
32nd SC meeting
6th (plan)
February, 2019
Cape Town (South Africa)
U.S.
37thSC meeting
The VICH Outreach Forum
Date
Venue
Sponsorship
Same period holding
1st
June, 2012
Brussels
EU
27th SC meeting
2nd
February, 2013
Washington D.C.
U.S.
28th SC meeting
3rd
November, 2013
Oakland
Japan
29th SC meeting
4th
June, 2014
Brussels
EU
30th SC meeting
5th
February, 2015
Washington D.C.
U.S.
31st SC meeting
6th
October, 2015
Tokyo
Japan
32nd SC meeting
7th
June, 2016
Brussels
EU
33rd SC meeting
8th
February, 2017
Buenos Aires
U.S.
34th SC meeting
5 Recent Activity
Summary of the 32nd SC Meeting (held in October 2015)
The activities of VICH moved to Phase 3 in 2015. In addition to development of new guidelines and monitoring/maintenance of existing guidelines, VICH has hosted the “VICH Outreach Forum” since 2012 along with the SC meeting as part of the dissemination activities of the VICH guidelines to countries/regions who have not participated in the activities of VICH.
At the 32nd SC meeting held in Tokyo in October 2015, SC adopted VICH PRIORITIES Phase 4: 2016-2020. In addition to the continuation of major activities (1. Development of VICH guidelines, 2. Revision of existing guidelines, 3. Collaboration with the OIE, 4. Contribution to the international efforts against the issues of drug-resistant strains, and 5. Review of the guidance of adverse effect monitoring), it was decided to extend the activities as follows: 1. Worldwide dissemination of the guidelines through the VICH Outreach Forum and contribution to animal health/animal welfare/public health, 2. Implementation of strategies for communication and training, 3. Understanding the needs of non-participant countries in VICH, 4. Pursuit of opportunities for developing VICH guidelines by leveraging ICH experience, and 5. Analysing the needs for guidelines for veterinary novel therapeutic products and initiate the development of their guidelines.