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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

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.

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