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
Steps | Phase |
|
drafting |
|
fine-tuning |
|
implemen- tation |
|
maitenance |
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. |
37th SC 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.