The Benefits of VICH to Emerging Countries Dr.Sasi Jaroenpoj ,DVM Department of Livestock Development THAILAND 27 – 29 October 2015 (Tokyo, Japan)
Why Participate in VICH ? (Benefits) Update activities
WHY Participate in ?
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
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
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
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
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
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)
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
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
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
How to access to VICH Outreach Forum member area Write to the VICH secretariat: sec@vichsec.org for ASEAN National focal point!
Thank You Very Much for Your Attention Emerging response for Your Attention Department of Livestock Development