Participation in the VICH process Active involvement in

Background • In 2010 IFAH-Europe first proposed to revise VICH GL 3 (R) Guideline

Current situation • With VICH Outreach Forum established re-opening the topic could make sense

th VICH SC Discussions at 29 • Very useful comments received • More in-depth

VICH SC conclusions • A much more detailed concept paper will need to be

Agreed next steps Þ Conduct of a survey with OIE Member countries Þ Creation

Slides: 7

Download presentation

Participation in the VICH process Active involvement in commenting concept paper (Presentation of revision GL 3 R) Brigitte Boenisch IFAH-Europe 3 rd VICH Outreach Forum Meeting th/13 th November 2013 Auckland, 12 1 1

Background • In 2010 IFAH-Europe first proposed to revise VICH GL 3 (R) Guideline on Stability: Stability Testing of New Veterinary Drug Substances and Medicinal Products • Rationale: current GL addresses stability requirements for climatic zones I and II. Today there is no “common” document or common consensus covering climatic zones III and IV. • Reviewed by VICH SC, but discussion on topic premature – no Outreach Forum yet 2 2

Current situation • With VICH Outreach Forum established re-opening the topic could make sense • Comments on Draft 3 of IFAH-Europe Concept Paper requested prior to discussion at 29 th VICH SC Meeting in Auckland • Input received from: 3 • Thai FDA • Camevet • Europe • AHI THANK YOU! 3

th VICH SC Discussions at 29 • Very useful comments received • More in-depth work is required for VICH SC to have all elements for decision-making on topic • Areas to address: 4 • Support from majority of OIE member countries that VICH defines conditions for stability testing for climatic zones III and IV => survey with OIE member countries • Active participation of VICH Outreach Forum members • Potential role of WHO guidance • Need for human and animal health products to stay aligned • More detailed impact assessment incl. resource implications (active substances used for both) 4

VICH SC conclusions • A much more detailed concept paper will need to be elaborated: • addressing the various areas of concern and reflection raised in the comments received, • identifying the full impact of the proposed work, • allowing to conclude on the feasibility/ probability of success of the work. 5 5

Agreed next steps Þ Conduct of a survey with OIE Member countries Þ Creation of a Task Force of experts Ø Led by IFAH-Europe Ø Working by electronic means Ø Including experts from countries in climatic zones III/IV (Australia, Outreach Forum volunteers) Have results available for 30 th VICH SC Meeting 6 6

THANK YOU FOR YOUR ATTENTION ! 7 7