1. The Vision for the Future
Session 9:
The Vision for the Future
Good afternoon, everybody.
I am very glad to see all of you in this session, and I am happy to show you about our vision to the future as an VICH Steering Committee (SC) member from the Ministry of Agriculture, Forestry and Fisheries of Japan (JMAFF).
At first I appreciate all person who contribute VICH 5 conference successfully, Japan Veterinary Products Association (JVPA), VICH Secretariat, VICH 5 Secretariat, and speakers.
Dr. Yuko Endo
JMAFF

2. 1. Outcome of VICH to the World 2. Phase 4 VICH Priorities (2016-2020)
3. Vision for the Future
This is the composition of my presentation.
At first, I will review the outcome of VICH to the world.
Then, I will introduce you the Phase 4 VICH Priorities, which was finalized just before the VICH 5 conference by Steering Committee. （この部分は未確定なので修正あり）
And at last, I will show you the vision for the future as my expectation.

3. Outcome of VICH to the World
At first, the outcome of VICH to the world.
As Dr. Orand gave the excellent presentation from OIE position just before me, I will speak this item shortly from the position of VICH SC member.

4. VICH has contributed to VICH regions
Harmonization of technical requirements in VICH regions
VICH Guidelines (53 final GLs)
Pharmaceuticals (40)
-Quality (14)
-Efficacy (10)
-Environmental Safety (2)
-Metabolism and Residues (4)
-Toxicology (7)
-Target Animal Safety (1)
-Antimicrobial Safety (2)
Biologicals (6)
-Quality (3)
-Target Animal Safety (3)
VICH established 53 final guidelines (GLs).
They are 40 GLs for pharmaceuticals, 5 for biologicals, and 7 general GLs.
Most of them are put into effect in VICH regions.
Quality GLs are similar to ICH GLs for human medicine, but efficacy, environmental safety, metabolism and residues, target animal safety and some other GLs are original ones for veterinary medicines.
These GLs are prioritized first by SC, and established through scientific discussion by expert working groups (EWGs), then approved by SC.
General (7)
-GCP (1)
-Pharmacovigilance (5)
-File Format (1)

5. VICH has contributed to the VICH regions
Harmonization of technical requirements in VICH regions
VICH GLs are very useful for VICH regions to
Ensure product quality, safety and efficacy
Reduce animal testing and costs of development
Accelerate the development and reviewing process
As the objectives of VICH is shown clearly in the VICH Charter opened to everyone on the VICH website.
The first one of the objectives of VICH are to establish and implement harmonized technical requirements for the registration of veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimize the use of test animals and costs of product development.
The wonderful effects of implementation of VICH guidelines in the VICH regions are shown in the screen.
・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
Ref. <Objectives in the VICH Charter>
- Establish and implement harmonized technical requirements for the registration of veterinary medicinal products in the VICH regions, which meet high quality, safety and efficacy standards and minimize the use of test animals and costs of product development.
- Provide a basis for wider international harmonization of technical requirements.
- Monitor and maintain existing VICH guidelines, taking particular note of the ICH1 work program and, where necessary, update these VICH guidelines.
- Ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following the implementation of VICH guidelines.
- By means of a constructive dialogue between regulatory authorities and industry, provide technical guidance enabling response to significant emerging global issues and science that impact on technical requirements within the VICH regions.
Increase availability of new veterinary medicinal products
Contribute to animal/public health, environment

6. Great Outcome of VICH for participants
Latest Science
Situations in VICH regions
Industries and regulators
Full Discussion to reach the best consensus in SC, Task Forces and EWGs
The first sentence in the guiding principles in the VICH charter is “The decision making process in VICH should be through consensus”, and another sentence is “Recommendations on GLs should be based on scientific assessment of existing information. “.
During the harmonization process, the members of the VICH SC, the Task Forces (TFs) and the EWGs have made continued discussion based on the latest science, and reach the consensus considering the situations of regulation or industry of the VICH regions. I think that the greatest outcome of the VICH activity is mutual understanding and trust among members from regulator and industry of VMP.
The harmonization is always achieved through best consensus after the sufficient discussion.
・・・・・・・・・・・・・・・・・・・
Ref.<Guiding Principles>
1. The decision making process in VICH should be through consensus.
4. Recommendations on guidelines should be based on scientific assessment of existing information. These guidelines should focus on the essential scientific requirements needed to address a topic and should eliminate unnecessary or redundant requirements.
9.All parties commit to provide the necessary human and material resources for the proper and timely functioning of VICH and execution of agreed work, subject to the general economic situation. The experts should be chosen both on scientific merits and ability to work within a multicultural team environment as well as on skills in negotiation/finding compromises.
10.The wider involvement of non-VICH countries should be encouraged, taking into account that continued efficiency in the operation of VICH should be preserved.
Mutual understanding & Trust among VICH participants

7. VICH GLs are useful for non-VICH countries
VICH and OIE aim to disseminate the outcome of VICH to the World through VICH Outreach Forum.
Russia
Canada EU
Ukraine
Korea
USA
Japan
China
Morocco
ASEAN
Taiwan
India
Thailand
Mexico
UEMOA
Malaysia
Brazil
In the screen, the VICH regions are shown as red letter, and VICH Outreach Forum countries/regions are shown in green letter.
You can see that all continents except the Antarctic Continent have red and green letters.
VICH and OIE aim to disseminate the outcome of VICH to the World through VICH Outreach Forum since 2012 to today.
The 6th VICH Outreach Forum meeting was held just before the VICH 5 conference, VICH SC members showed latest VICH activities and many items concerning to VICH and veterinary medicines, and they are discussed actively among the participants.
If countries/regions out of VICH implement the guidelines, I believe that the same wonderful effects as seen in VICH regions will be expected in the countries/regions.
Australia/
New Zealand
CAMEVET
South Africa
Argentina

8. 2. Phase 4 VICH Priorities
Next item is Phase 4 VICH Priorities.

9. Draft-VICH Priorities Phase 4: 2016-2020
This presentation is made based on the draft 4 – VICH Priorities Phase 4: (14 September 2015)
1. History
2. The Scope of VICH
3. Drivers behind the priorities for VICH phase 4
4. Priorities for the period
This presentation was made based on the draft 4 of VICH priorities phase 4.
The final version has only minor change from this draft version, and soon will be published on VICH website. （この部分は修正される可能性あり）
The document is composed of 4 chapters.
History, the scope of VICH, drivers behind the priorities for VICH phase 4, and priorities for the period 2016 to 2020.
VICH Steering Committee will soon publish the phase 4 VICH Priorities for next five years ( ) on the VICH website (

10. Draft-VICH Priorities Phase 4: 2016-2020
3. Drivers behind the priorities for VICH phase 4
The drivers for VICH phase 4 include:
Needs to produce/maintain VICHGLs
Desire to expand geographical reach of VICH (VICH Outreach Forum)
Desire for effective cooperation with the OIE
Drive to Harmonize Technical Requirements
Desire to Reduce the Use of Animals
Needs to recognize Threat of Antimicrobial Resistance (AMR)
Need for Efficient Use of Resources
Desire to Minimize the Cost of gaining Registration
Opportunity to benefit from ICH
The chapter 3 drivers behind the priorities for VICH 4 include 9 items shown in the screen.
They are
-The needs to produce/maintain VICHGLs
-The desire to expand geographical reach of VICH (VICH Outreach Forum)
-The desire for effective cooperation with the OIE
-The drive to Harmonize Technical Requirements
-The desire to Reduce the Use of Animals
-The needs to recognize Threat of Antimicrobial Resistance (AMR)
-The need for Efficient Use of Resources
-The desire to Minimize the Cost of gaining Registration
-The opportunity to benefit from ICH

11. Draft-VICH Priorities Phase 4: 2016-2020
4. Priorities for the period
VICH will continue the following key activities.
Establish VICH GLs
Update/revise VICH GLs
Collaboration with the OIE
Contribute the international efforts to minimize the risks of AMR*
Review guidance for pharmacovigilance reporting
The chapter 4 the priorities for the period 2016 to 2020 was constituted with 2 categories of key activities.
The first category is continued activities, and the second one is new activities.
This slide shows the continued key activities.
They are to establish VICH GLs, to update/revise VICH GLs, collaboration with the OIE, to contribute the international efforts to minimize the risks of antimicrobial resistance (AMR), and to review guidance for pharmacovigilance reporting.
In addition to AMR, TF of anthelmintics GLs discussed including resistance to endo/ecto-parasiticides. (If the SC adopt this topic, the EWG will be re-established and make discussion about revision of all anthelmintic s GLs.)
*Task Force of Anthelmintics GLs discussed including resistance to endo/ecto-parasiticides.

12. Draft-VICH Priorities Phase 4: 2016-2020
4. Priorities for the period
VICH will expand activities in the following areas.
Wider International Harmonization (particularly VICH Outreach Forum)
Finalize a Communication and Training Strategy to raise awareness of the benefit of VICH
Consider the Needs and Priorities of non-VICH Countries about technical Requirements for the registration of VMPs
Identify Opportunities to Benefit from ICH Experience in the development of GLs
Analyze the Need for Developing Guidance on Registration Requirements for Veterinary Novel Therapy Products
This slide shows the new key activities.
VICH will expand activities in these areas.
They are wider international harmonization particularly VICH Outreach Forum, to finalize a communication and training strategy to raise awareness of the benefit of VICH, to consider the needs and priorities of non-VICH countries about technical requirements for the registration of VMPs, to identify opportunities to benefit from ICH experience, and analyze the need for developing guidance on registration requirements for veterinary novel therapy products.

13. 3. Vision for the Future
This is the last item of my presentation, I will show you the vision for the future as my personal expectation.

14. Vision for the future Reaching out to the World Future 2020 2015
(VICH Phase 4)
This blue point is 2015, at present time, and we discussed various theme in VICH 5 conference entitled “Reaching out to the World”.
And VICH SC agreed (or are trying to agree) to the VICH Phase 4 priorities from 2016 to 2020.
However, do you think that VICH will be needed after 2020?
I think “yes”, we will need VICH activities after 2020.
Why do I think that we will need VICH in the future?
Because VICH provide a basis for wider international harmonization, and VICH will be able to contribute to realize the one health in the world in the future.
From my 19 years-experience in VICH activity, I believe that VICH will promote the one health in the world.
Reaching out to the World

15. Desirable Future World for People & Animals
All people, domestic animals, wildlife are in good health.
No hunger is in the world.
Environment is healthy and ecosystem functions well.
One Health
Human in good Health
Domestic Animals in good Health
Wildlife in good Health
Good Food Supply and Economies
Healthy Environment
Good Functioning Ecosystem
This slide shows the desirable future world for people and animals I am dreaming.
All people, domestic animals and wildlife are in good health, no hunger is in the world, and environment is healthy and ecosystem functions well.
In this slide, I show you the 6 components important for one health.
They are human health, domestic animal health, wildlife, food supply and economy, environment and ecosystem.
I think that VICH contributes directly to domestic animal health and good food supply and indirectly to human health at present time, however, I believe VICH will be able to more contribution in all of 6 areas in the future.

16. Probable VICH contribution to Health
Quick development of new VMPs.
VICH
Human Health
Animal Health
Wildlife Health
Good Food Supply
Environ-ment
Eco-system
Examples of Areas
-new infectious diseases
-zoonosis
-chronic diseases
-alternative toxicity tests
-improve QOL of animals
-novel therapy
This slide shows the probable VICH contribution to human health, animal health and wildlife health in the world.
The activity of VICH promotes the quick development of new VMPs, the supply of VMPs with high quality, efficacy and safety, and VICH helps the easily access to enough VMPs with fair price in all if the worlds.
For examples of health area contribution, I expect VMPs in new infectious diseases, zoonosis, chronic diseases, alternative toxicity tests which promote 3Rs, to improve quality of life (QOL) of animals, and novel therapy to animal diseases.
Supply of VMPs with high quality, efficacy & safety.
Easily access to enough VMPs with fair price in all of the world.

17. Probable VICH contribution to Food Supply
Quick development of new VMPs.
VICH
Human Health
Animal Health
Wildlife Health
Good Food Supply
Environ-ment
Eco-system
Examples of Areas
-healthy growth & efficient production
-produce safe foods with high quality
-reduce residues of VMPs in foods
This slide shows the probable VICH contribution to good food supply in the world.
For examples of this area contribution, I expect VMPs useful to health growth and efficient production, VMPs useful to produce safe foods with high quality and useful to reduce residues of VMPs in foods.
VICH toxicology GLs are very useful to collect the data necessary to evaluate the safety of residues of veterinary drugs in human food. Metabolism and residue GLs are very useful to collect the data of the depletion of drug residues after the administration of VMPs, these are the essential data to establish the withdrawal periods for the VMPs.
In the future, progress in pharmaceutical science, toxicology and analytical chemistry will realize the development of VMPs with reduced toxicity and residues. In future VICH we will be able to determine the harmonized technical requirements of new technology in these fields.
Supply of VMPs with high quality, efficacy & safety.
Easily access to enough VMPs with fair price in all of the world.

18. Probable VICH contribution to Environment
Quick development of new VMPs.
VICH
Human Health
Animal Health
Wildlife Health
Good Food Supply
Environ-ment
Eco-system
Examples of Areas
-VMPs with no harmful effects for ecosystem
-Easily degradable VMPs in the ecosystem
-Collection and adequate treatment of used VMPs
This slide shows the probable VICH contribution to environment and ecosystem.
For examples of this area contribution, I expect the technology to develop VMPs with no harmful effects for ecosystem, develop easily degradable VMPs in the ecosystem.
VICH environmental safety GLs clearly describe the nature which is harmful to environment, and we can assess the safety of VMPs using these GLs. Therefore, we can take environmental safety into account on the stage of development of VMPs by using VICH GLs. These VICH GLs are referring OECD GLs for testing of chemicals. As OECD GLs for testing effects on biotic systems and for testing degradation and accumulation are developed one after another, VICH GLs have possibility to be improved in the future.
The third example in the slide shows that “Collection and adequate treatment of used VMPs”. At present time, environment is one of the important subject of social responsibility. I think that we will be able to do something good in the future to prevent pollution of water and soil from the used VMPs.
Supply of VMPs with high quality, efficacy & safety.
Easily access to enough VMPs with fair price in all of the world.

19. Vision for the Future VICH Outreach have various possibilities,
for example,
-Regional dossiers and global dossiers with some regional differences
-Harmonized/aligned pharmacovigilance systems
Global regulatory convergence
VICH have a potential to contribute to the world sounder and happier through the outreach activity.
VICH outreach to non-VICH countries/regions is one of the most important key issues of future VICH activities.
VICH Outreach have various possibilities in the future, for example, regional dossiers and global dossiers with some regional differences, harmonized/aligned pharmacovigilance systems, and global regulatory convergence.
VICH have a potential to contribute to the world sounder and happier through the outreach activity.

20. Vision for the Future
VICH welcome collaboration with non-VICH countries, and VICH sincerely wish to improve the health for both human and animals by supplying the VICH standards and knowledge for the world.
At last, I am very happy to closing my presentation with these words.
VICH welcome collaboration with non-VICH countries, and VICH sincerely wish to improve the health for both human and animals by supplying the VICH standards and knowledge for the world.

21. Thank you for your Attention!
Thank you very much for your attention!
Thank you for your Attention!