1. The Benefits of VICH to Emerging Countries
Dr.Sasi Jaroenpoj ,DVM
Department of Livestock Development
THAILAND
27 – 29 October (Tokyo, Japan)

2. Why Participate in VICH ? (Benefits)
Update activities

3. WHY Participate in ?

4. Primary Benefits of VICH
Use of Internationally harmonised guidelines to;
Ensure product quality, safety and efficacy
Reduce animal testing and costs of development
Accelerate the development and reviewing process
Increase availability of new VMPs
Contribute to animal/public health, environment
Unique opportunity for;
Regulators and industry to discuss regulatory data requirements
Discussion between worldwide scientific experts

5. Secondary Benefits of VICH
Better understanding of regulations and concerns in the other regions
Opportunity to update regional regulations
A basis for future global harmonisation of registration guidelines
Opportunity to discuss emerging global issues and relevant science
Contribute to the Global One Health approach

6. Latest VOF topics (2014)-1
Report on the development of a training and communication strategy,
Outlining VICH’s current thoughts, and requesting feedback from the VOF members;
Progress reports of the Task Forces
Revision of the guideline on stability : in Climate Zone III and IV (hot and hot/humid climates)
New guideline on efficacy for combination products originally proposed by China

7. Latest VOF topics (2014)-2 Presentation
- Links between the legal frameworks for VMPs and VICH GLs in Japan, Canada and EU
- ASEAN Cooperation on Veterinary Medicinal Products
Training presentations
Generics : definitions and related terms
Technical aspects of bioequivalence
Waiving of target animal batch safety testing
How to comment on VICH guideline

8. Latest VOF topics (2014) -3
Updates from VICH Outreach Forum participants
Implementation of VICH guidelines
National/Regional activities regarding VMPs
Group discussions of questions to VOF members and feedback to the SC

9. Latest VOF topics (2015)-1
Report on the development of a training and communication strategy,
Many materials available on the VICH public website
SC will discuss to identify funding opportunity to support VICH level 2 training program
Progress reports of the SC
Not develop GL on efficacy study for combination products containing antimicrobial substances (scope anthelmintic)
Develop GL on stability in climate zone III and IV separate from existing GL (ultimate goal for non-VICH countries)
(CAMEVET will provide its expertise to the EWG)

10. Latest VOF topics (2015)-2 Group discussion Topic
TABST and Bioequivalence
Application of VICH GLs
Information from
CAMEVET : details member countries that use the original or modified VICH GLs
China : existing Chinese GLs will be modified to include the VICH GL elements
Thailand : Will propose some GLs to consider at the next ASEAN meeting

11. Latest VOF topics (2015)-3 Participation in VICH process
The procedure for the registration of animal vaccines in ASEAN
How to comment on a draft VICH GL
OIE confirmed that the drafted GL are circulated each time with request for comment
CAMEVET sends the drafted GL to its focal point in its member countries
China translated into chinese and distributed to 10 experts to provide their comment within 10 working days National focal point send them to VICH secretariat

12. Latest VOF topics (2015)-4 Training presentations
GLP/GCP requirement and implementation
EU explained how Pharmacovigilance systems and processes are developed
Topic propose for next presentation
Aquaculture product and VICH MRL GL for fish and honey
Herbal medicine
Review of AMR GL 27,Anthelmintic GL
Implementation of TABST in the 3 VICH regions
Bioequivalence and generic policy
Training strategy

13. How to access to VICH Outreach Forum member area
Write to the VICH secretariat:
for ASEAN National focal point!

14. Thank You Very Much for Your Attention
Emerging response
for Your Attention
Department of Livestock Development