Application of VICH GLs extract from group discussion

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

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

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

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

Application of VICH GLs Thailand: • Do not use VICH GLs today • Require dossier from company, have subcommittee for registration of VMP (university, Mo. H) • 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

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

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 80 ies: – gradual adaptation was allowed for, – positive effect was an enlarged market, – little negative effects observed (few companies went out of business) 7

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

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