1. Application of VICH GLs – extract from group discussion General: VICH GLs do not prescribe the data package to be submitted for registration, they merely provide guidance on how studies should be conducted VICH GLs apply to NEW applications/submissions to vary the authorisation (e.g. additional species) only – an important message Updates may need use of VICH GLs also Pharmacovigilance as an exception ² 1

2. Application of VICH GLs VICH process/outreach: Local governments concerned about the system of adopting VICH GLs being very different from OIE/CODEX system => only few countries represented; not equivalent to OIE/CODEX Projection into future – 10 years from now: moving into animal protein-based economy; need for VMPs to manage the animal populations What do we need to aim for in the future? What does it take to get there? Resources required to manage CODEX process Topic needs further discussion!!! 2

3. Application of VICH GLs Observers: Sometimes not all elements can be adopted, however, philosophy is always followed and main part applied Where application is not 100%, to ensure predictability it is important to clearly highlight in the GL any differences in local implementation Specifically required details might locally not be suitable (e.g. specific diseases, animal species) => GL can be implemented to a lesser extent; spirit needs to be recognised 3

4. Application of VICH GLs Existing products: VICH GLs apply to new applications – no retrospective application of VICH GLs to existing products Basic concept in Europe: authorised products recognised to be safe unless new information indicates otherwise Argentina: –No concept of generics, i.e. all products are new products and require full dossier –once molecule approved for first time, accept bibliography (e.g. pharmacology, toxicology) complemented by local trials (residues, TAS, efficacy) => Local industry concerned no concept of generic product 4

5. Application of VICH GLs Thailand: Do not use VICH GLs today Require dossier from company, have subcommittee for registration of VMP (university, MoH) Instructions for testing vaccines exist (OIE GLs), no GLs for pharmaceuticals currently Have products with “same” composition registered and on the market Intend to propose the use of some VICH GL for ASEAN meeting in Thailand; meeting of 10 ASEAN countries in Thailand 1 st - 3 rd April 2015; topic of using VICH GL will be on agenda 5

6. Application of VICH GLs China: Already a lot of Chinese GLs in place (about 30) for pharmaceuticals, vaccines and herbal medicines With active VOF participation gradually changing strategy and using VICH GL, e.g. TAS, BE in future, but also others (e.g.toxicology, residues) Existing Chinese GLs will be modified to include the VICH GL elements Chinese government needed to get acquainted with VICH and its GLs before moving towards their use VICH GLs being translated into Chinese (resources, time) 6

7. Application of VICH GLs Local industry: Adaptation phase required to allow local industry to adjust, needs to be phased, gradual process Experience in EU environment with harmonised standards being applied from the 80ies: –gradual adaptation was allowed for, –positive effect was an enlarged market, –little negative effects observed (few companies went out of business) 7

8. Application of VICH GLs OIE (Asia): OIE has local office in Bangkok; main focus of discussions today are vaccines; no currently much involved in harmonisation discussions in Asia Discussions very different from VICH – health standards as basis of international trade (OIE) vs. technical requirements in the context of regulatory framework (VICH) 8

9. Application of VICH GLs Africa: Several regional initiatives looking a common approaches to vaccines, less activity for registration of VMPs UEMOA – Centralised procedure for registering VMPs in Western Africa – good concept, practical implemention lagging behind Morocco – recently much progress made in regulating VMPs well with positive impact on data generation SADC – southern part of Africa; regional initiative; GLs referring to VICH; collaboration between countries well progressed on human side, looking into adapting the principle for VMPs – gaining momentum again 9