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- What is VICH, History and Objectives

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1 - What is VICH, History and Objectives
Hervé MARION, DVM VICH Secretariat

2 What is VICH VICH – the History Role & Objectives Conclusion

3 I. What is VICH ?

4 What is VICH? VICH = International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products International cooperation programme US - JAPAN - EU (+ AUS - NZ - Canada - South Africa as observers) Discussion Forum for Regulatory Authorities and Industry

5 VICH = International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VMPs) Full Members Russia Canada EU Ukraine Korea USA Japan PRC Morocco ASEAN Taiwan UEMOA India Thailand Outreach Forum Mexico Nige ria Saudi Arabia Uganda Malaysia Brazil Zambia Zimbabwe Australia New Zealand CAMEVET South Africa Argentina Observers OIE : Associate Member, HealthforAnimals: Secretariat

6 VICH Steering Committee
VICH Structure VICH Steering Committee VICH Outreach Forum VICH Secretariat OIE Ad Hoc Task Forces Expert working Group

7 The Steering Committee (SC)
The management body of VICH Status Country/Region Number of participants Government Industry Full members Japan 3 EU USA Observers Australia 1 New Zealand Canada South Africa Associate member World Organisation for Animal Health (OIE) Interested Party AVBC: Association of Veterinary Biologics Companies Secretariat HealthforAnimals

8 The VICH Steering Committee
Is the decision making body of VICH and drives the process Determines the priority items based on concept papers prepared by its members Sets up the appropriate Expert Working Groups (EWGs) and appoints topic leaders and EWG chairpersons; Approves the draft Guidelines prepared by EWGs before release for public consultation Approves (ONLY the regulatory authorities from the EU, Japan and the USA) the final Guidelines for implementation in the member regions Is responsible for a programme of monitoring maintenance and review of Guidelines

9 The VICH Expert Working Groups (EWG)
The SC establishes an EWG with a specific mandate Active EWGs Safety Quality Biological Quality Monitoring Bioequivalence ESI (Pharmacovigilance) Metabolism & Residue Kinetics Revision of Anthelmintics GLs Combination Products GLs Participants for each EWG Country/Region Number* Government Industry Japan 1 EU USA Observers *Each member and observer may send one additional advisor when required. Experts from VOF countries may also be appointed if appropriate.

10 II. VICH The History

11 VICH History & Milestones
1980’s - 90’s First talks & Meetings on VMP harmonisation 1990 - ICH (human medicines) 1991 Creation of ICH with 1st conference 1992 7th ITCVDR conference in Argentina: concept of VICH OIE ad hoc Group on the VMP Harmonisation: scope, membership and objectives of VICH April 1996 1st VICH Steering Committee in the OIE headquarters in Paris, France Nov. 1999 1st VICH Public Conference in Brussels, Belgium Oct. 2002 2nd VICH Public Conference and 11th Steering Committee meeting in Tokyo, Japan

12 VICH History & Milestones
May 2005 3rd VICH Public Conference and 16th Steering Committee meeting in Washington DC, USA June 2008 First reflection on Global Outreach June 2010 4th VICH Public Conference , 24th Steering Committee and plenary exchange on Global Outreach Strategy in the OIE headquarters November 2011 Contact meeting with selected non-VICH country representatives in Tokyo, Japan June 2012 1st VICH Outreach Forum meeting in Brussels, Belgium October 2015 5th VICH Public Conference, 6th VICH Outreach Forum meeting and 32nd Steering Committee in Tokyo, Japan February 2019 6th VICH Public Conference, 11th VICH Outreach Forum meeting and 37th Steering Committee in Cape Town, South Africa

13 VICH Process International Meetings
Rotation between the 3 member regions 37 Steering Committee meetings Every 9 months 11 VICH Outreach Forum meetings 6 VICH Public Conferences Every 4 to 5 years Expert Working Groups work through s, teleconferences and face-to-face meetings to progress their work Ad hoc and ongoing

14 The VICH Outreach Forum (VOF)
Chaired by VICH/OIE Objectives: Wider international harmonisation Raising awareness of VICH Good governance of VMPs worldwide Matters addressed: How to participate in VICH work Practical issues for accepting and using VICH Guidelines Sharing of translations of Guidelines Development of pharmacovigilance Collating comments from the initial stage of Guideline creation, etc….

15 The VICH Outreach Forum (VOF)
Current members Continent Country Regional Organisation Eurasia Peoples Republic of China, India, Korea, Malaysia, Taiwan, Thailand Russia, Ukraine ASEAN North Africa Morocco Africa Nigeria, Zambia, Zimbabwe, Uganda UEMOA Middle East Saudi Arabia America Argentina, Brazil, Mexico CAMEVET

16 VICH Guidelines Category Pharmaceuticals Biologicals General
GL numbers Pharmaceuticals Quality 1, 2, 3, 4, 5, 8, 10, 11, 17, 18(R)*, 39, 40, 45, 51, 58 Efficacy　 7, 12, 13, 14, 15, 16, 19, 20, 21 Environmental Safety 6, 38 Metabolism and Residue 46, 47, 48(R), 49(R), 56, 57 Toxicology 22, 23, 28, 31, 32, 33, 37, 54 Target Animal Safety 43 Antimicrobial Safety 27, 36 Biologicals 34, 25, 26 41, 44, 50, 55 Bioequivalence 52 General GCP 9 Electronic File Format 53 Pharmacovigilance 24, 29, 30, 35, 42

17 III. VICH Role and Objectives

18 What is the role of VICH? To harmonise technical requirements for data necessary for registration of a veterinary medicinal product To develop and implement VICH Guidelines Study and testing methodology Quality, safety and efficacy (including bioequivalence) Post-marketing safety monitoring Pharmacovigilance

19 It is NOT the role of VICH to:
Provide guidance to establish regulatory systems and regulations for marketing authorisations for Veterinary Medicinal Products Decide which studies are necessary to obtain a marketing authorisation Assess data or provide guidance on the assessment approach Grant marketing authorisations Establish safety standards These are typically the roles of national competent authorities and governments!

20 VICH Objectives Establish and implement harmonised requirements for veterinary medicines in the VICH regions, which Meet high standards of Quality, Safety & Efficacy to protect public health, animal health & welfare and the environment Minimise the use of test animals and costs of product development Provide a basis for wider international harmonisation of technical requirements Ensure efficient processes for maintaining and monitoring consistent interpretation of data requirements following implementation Provide technical guidance enabling response to significant emerging global issues and science of relevance

21 VICH Guiding Principles
The decision making process in VICH should be through consensus Procedures should ensure the smooth and consistent functioning of the process for preparation, consultation and adoption of Guidelines New topics for development of Guidelines are agreed following evaluation of importance and feasibility of project; requires acceptance of all full VICH members Harmonised requirements should replace corresponding regional requirements Transparent and cost-effective procedures, open for public comments Consultation by all regulatory authorities in VICH Consultation procedure by dissemination to OIE Member Countries through OIE VICH public website

22 IV. Conclusion

23 Achievements Confidence building and close collaboration between the participants since 1996! Considerable improvements of harmonization of data requirements between regions, thus Reduction of animal testing Reduction of costs Better understanding of regulations and concerns in the other regions Discussion forum between scientific experts from both Regulatory agencies and the Animal Health companies Contribute to the Global One Health approach

24 Achievements All decisions in the SC and the EWGs are made by consensus Unique opportunity for regulators and industry to discuss topics openly enabling a pooling of expertise to jointly draft guidelines on regulatory data requirements Opportunity to update regional standards Acceleration of Veterinary Medicinal product development for Livestock & Companion Animals Increase availability of Veterinary Medicines Increased Product Safety and Consumer Safety

25 The VICH public website (http://www.vichsec.org)
25 25

26 THANK YOU FOR YOUR ATTENTION!

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