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VICH General Principles and

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Presentation on theme: "VICH General Principles and"— Presentation transcript:

1 VICH General Principles and
current update of VICH Outreach Forum activity

2 WHAT Is VICH? WHY Participate in? HOW to Participate in?

3 What Is VICH?

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

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

6 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 Efficacy　 7, 12, 13, 14, 15, 16, 19, 20, 21, 52 Environmental Safety 6, 38 Metabolism and Residue 46, 47, 48(R), 49(R) Toxicology 22, 23, 28, 31, 32, 33, 37 Target Animal Safety 43 Antimicrobial Safety 27, 36 Biologicals 34, 25, 26 41, 44, 50 General GCP 9 Pharmacovigilance 24, 29, 30, 35, 42 Electronic file formats 53

7 It is NOT the role of VICH to:
Provide guidance to establish regulatory systems and regulations for marketing authorisations Make final decision 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!

8 How the roles of VICH, OIE & Codex differ?
Supports its Member Countries in; Improving the legal framework and resources capacity of national veterinary services Setting standards on animal production, food safety, etc… Sets terrestrial/aquatic animal health codes  OIE standards Develops international food safety standards, guidelines and related texts such as; Maximum residue limits (MRLs) of veterinary drugs in foodstuffs from animal origin Codes of practice to protect consumers and ensure fair practices in the food trade  Codex food standards Both OIE standards and Codex food standards are recognized by WTO as references for international trade

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

10 Steering Committee (SC)
Management of VICH Status Country/Region Number of participants Government Industry Full member Japan 3 EU USA Observer Australia 1 New Zealand Canada South Africa

11 VICH Outreach Forum (VOF)
Chaired by VICH/OIE for; Wider international harmonisation Raising awareness of VICH Good governance of VMPs worldwide Matters to be addressed; How to participate in VICH work Practical issues for accepting and using VICH guidelines Sharing of translations of guidelines Collating comments from the initial stage of guideline creation, etc…. Current members Continent Country Regional Organisation Eurasia China, India, Korea Malaysia, Taiwan, Thailand Russia, Ukraine ASEAN Africa Morocco, Uganda UEMOA America Argentina, Brazil, Mexico CAMEVET Middle East Saudi Arabia

12 Expert Working Group (EWG)
SC establishes EWG with a specific mandate Active EWGs Safety Quality Biological Quality Monitoring Bioequivalence Electronic Standards Implementation (Phamacovigilance) Participants for each EWG Country/Region Number* Government Industry Japan 1 EU USA *Each member may send one additional advisor when required. Experts from observer or VOF countries may also be appointed or requested.

13 VICH -the History Foundation & Expansion
1980’s - 90’s First talks & Meetings on VMP harmonisation 1990 - ICH (human medicines) OIE ad hoc Group on the VMP Harmonisation 1996 - VICH 2011 - VICH Outreach Forum (VOF) International Meetings 33 Steering Committee meetings Every 9 months 4 VOF meetings 5 VICH Public Conferences Every 3 to 5 years

14 VICH guideline creation process
Step Stage 1: SC agrees to start a topic and appoints an EWG 2: EWG elaborates a draft GL 3: SC approves the draft GL for public consultation Drafting 4: Draft GL is circulated to stake holders and public 5: EWG prepares a revised GL 6: SC approves the revised GL Fine-tuning 7: Final GL is circulated to authorities of VICH region 8: Final GL is implemented in VICH region Publishing 9: SC monitors, maintains and reviews the GL Maintenance

15 WHY Participate in ?

16 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

17 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

18 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

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

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

21 HOW to Participate in?

22 All the members can participate!
OIE members can send comments to draft guidelines during the public consultation Encouraged to use VICH guidelines as national or regional guidelines Free of charge If you wish to go one step forward Deeper understanding of VICH-GLs Learning how to implement and use VICH-GLs Proposing new topics of interest Involved in drafting GLs as an EWG member VOF may be your choice

23 How to be a VICH Outreach Forum member
The criteria for participation in VOF: Regulation for marketing authorization in place Willingness to work towards accepting VICH guidelines Regular participation to VOF meetings (every 9 months) Paying for participation (travel costs, accommodation) Interested in participating in VOF activity? Write to the VICH secretariat: for more information, today!

24 The VICH public website (http://www.vichsec.org)
24 24

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