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Activities in VICH

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
  • 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
 drafting
  • 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
 fine-tuning
  • Step7:Send the GL to the regulatory authorities of each country with the enforcement date
  • Step8:Implementation of the GL in each region
 implemen-
 tation
  • Step9:Review of the GL (monitoring and maintenance)
 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

6thplan

 

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.