Waiving TABST for vaccines Argentina: Not an allowed procedure today Require batch safety tests in laboratory animals, repeated by authorities Currently under evaluation whether application is possible in the future Imported vaccines from Europe: up to now no problem with fact that TABST is waived Need more training on concept, analysis and science behind – OIE also important in defending concept Consequences are not only technical – impacts also administration employment 1

Waiving TABST for vaccines Thailand: Ministry of Public Health for Marketing Authorisation Post-marketing is Ministry of Agriculture, Department of Lifestock (reference laboratory of ASEAN countries): sampling of vaccines from market (laboratory animal testing) New regulation in near future: Animal vaccines in the future will be with Ministry of Agriculture Will be able to reduce the testing based on VICH GL 2

Waiving TABST for vaccines Japan: TABST no longer for inactivated vaccines if data from 10 consecutive batches GL for waiver of TABST for live vaccines under way 3

Waiving TABST for vaccines China: Both tests (laboratory animals & TABST) need to be done Once marketed authorities take samples from the market and do both tests Balance risk to livestock with 3Rs concept Have not yet established a PV system – need to develop GL Taking samples is a supplementary measure to ensure the safety of vaccines 4

Bioequivalence Argentina/CAMEVET: Work on BE GL – directed to establish the way to design a good protocol for a BE study Currently refer to FDA GL, had only 3 real cases in Argentina up to now Impact of regulatory system for approval of products: need to learn how to work with BE as tool (e.g. for varying marketing authorisations) Need to identify the role of BE in the regulatory system since no system for generics in Argentina today 5

Bioequivalence Argentina/CAMEVET: Example: use of BE for slight changes in product composition => tool could be used to waive efficacy studies Ask for full dossier for all new products – is a cost issue for industry; certain efficacy trials could be approved based on bibliography, others cannot be waived in Argentina (e.g. mange) => labels for “same” drug could be different Most products in Argentina are prescription only Practical aspect: today difficult to find experts to perform BE studies 6

Bioequivalence China: Did not in the past have the concept for generic products; will establish a legal definition this year In the past did not implement BE requirements; will establish this year; looking at VICH GL as well as existing regional GLs for study requirements Generics: same composition as original product Shortest time 3 years, longest time 5 years until generics is allowed 7

Bioequivalence Thailand: BE concept exists for human drugs, not yet for veterinary 8

Bioequivalence Other aspects: Difference between human and vet products – many injectable drugs on animal health side Europe: residue data requirements for generic injectable products - impact of formulation Europe: biosimilars provision in legislation, not really applicable in practice since each vaccine is a new product; generic concept works mainly for pharmaceuticals How to establish the sameness of several products? Is a practical problem eg in Argentina – generics with same active ingredient but different withdrawal periods 9

Bioequivalence Other aspects: US requires generics to do BE studies for all species on originator label 10