1. VICH Task Force for Efficacy Studies for Combination Products Progress Report (Final) VICH members JMAFF (chair)K. Noda JVPAE. Oishi IFAH-EUM. Bobey EUK. Healey US FDAC. Groesbeck AHIB. McKusick Observer South Africa, Nat. Dept. healthV. Naidoo VOF members China PR, IVDCS. Xu Argentina, SENASAL. Sbordi Taiwan, Council of AgricultureT-R. Jan UEMOAK.Th. Domagni CAMEVETL. Sbordi Additional contributors Australia, APVMAP. Reeves NZ, Min. Primary IndustryW. Hughes

2. Introduction  At the 3 rd VOF meeting in Nov 2013, China PR presented a Concept Paper for a VICH guideline on “efficacy studies for combination drug products”.  The SC & VOF members welcomed the proposal confirming that it is an important topic where guidance is currently lacking.  The scope of this topic is very broad and could lead to several GLs.  It would be useful to identify the different combinations available in order to reach agreement on which GLs should be developed. The SC decided to create a task force (TF) chaired by JMAFF.

3. Mandate  To elaborate a discussion paper proposing a more focused scope for the development of a VICH GL for efficacy studies for combination products.  The TF will  Prioritize the target products  Explore the possibility of a general policy document >Explore Major combination >Analyse GLs already in Place

4. Major Combination-products

5. TitleCategoryScope EU Guidance on pharmaceutical fixed combination products General EU data requirements for efficacy, safety and residues documentation for veterinary medicinal products, containing 2 or more active substances. US CVM GFI #24 Drug Combinations for Use in Animals General Information and data to demonstrate that the combination of drugs provides a benefit that cannot be obtained by the use of each of the drugs individually Aust. WAAVP guideline: (Adopted as National GL in Australia) Anthelmintic combination products targeting nematode infections of ruminants and horses Antiparasitics A scientific basis for the approval Anthelmintic products with two or more constituents with similar spectra of activity from different pharmacological classes For use in addition to the existing requirements/GLs for single-API products. Technical Requirement GLs in Place WAAVP: World Association for Advancement of Veterinary Parasitology

6. Conclusion  General combination GL  EU and US are the representative General GLs.  Internationally harmonized GL by extracting appropriate elements from them.  Specific combination GL  Main target : Anti-Parasitics  Drug resistance control will be a main objective.  Inclusion of WAAVP/Australian GL into VICH framework should be explored in collaboration with the Anthelmintics-EWG.  Other specific combination may be a target in the future.  After some experiences  Further discussion by the VOF and SC members needed

7. Thank you 感謝