MUMS- Perspective of Japanese Situation

1. MUMS- Perspective of Japanese Situation TatsuroSekiya, DVM   National Veterinary Assay Laboratory The Ministry of Agriculture, Forestry and Fisheries of Japan

2. Japanese Background Increasing Interest in MUMS • Eating habits have become diversified. • Increasing needs for healthful diets.

3. Japanese Background Increasing Interest in MUMS • Higher standards of animal hygiene and veterinary practice • Growing awareness about animal welfare • A great variety of companion animals

4. Japanese Background Pharmaceutical industries are reluctant to develop MUMS and make efforts to get approval. • Development costs have been expanded due to GLP studies, GCP studies, etc. • Unprofitable Poor prospects for sales volumes; cannot pay the development costs • Economic recession Mergers and acquisitions among pharmaceutical companies

5. Japanese Situation of Minor Species Animals Definition of Minor Species Animals? ･No legislative definitions Generally regarded as minor species animals : Animals other than major species animals

6. Japanese Situation of Minor Species Animals • Definition of Major Species Animals? ･No legislative definitions ･Generally regarded as major species animals: Cattle, swine, chickens, cultured fish, dogs and cats.

7. Japanese Situation of Minor Species Animals Honeybees (Horses) minor? Sheep

8. Japanese Situation of Minor Species Animals Emu Ostrich Geese Deer

9. Approved animal drugs : more than 4,000 in Japan ･ Limited numbers and kinds of drugs approved for horses sheep goats honeybees quail turkey aquarium fish pet birds ･No drugs approved for ostrich ducks deer exotic pet animals zoo animals laboratory animals pet reptiles pet insects etc.

10. Japanese Situation of Minor Use Definition of Minor Use ? ･No legislative definitions Generally regarded as minor use: Drugs for uncommon diseases (Little or inconstant demands for drugs)

11. Japanese Situation Shortage of MUMS Limited therapeutic, preventive and diagnostic options Potential problems concerning animal hygiene, veterinary practice and human health

12. Japanese Situation Shortage of MUMS Extra-label use of human drugs or drugs approved for other animal species Rely on veterinarian’s skills for judging Safety?Efficacy? Withdrawal period? Potential problems concerning food safety, veterinary practice andanimal hygiene

13. Japanese Regulatory Requirements:Data requirements for the new drug approval under the Pharmaceutical Affairs Law • Data on origin, details of discovery, etc. • Data on physical and chemical properties, test methods etc. • Data on stability • Data on toxicity • Data on safety for target animal • Data on pharmacological action • Data on absorption, distribution, metabolism and excretion • Data on results of clinical trials • Data on residue study

14. Japanese Regulatory Requirements • Applications for MUMS approval require all the data obtained in compliance with relevant regulations and guidelines • No regulatory system like the process of ‘Orphan Drug’ approval for human use

15. Japanese Situation Difficulty to perform studies required for the application for approval Limited availability of GLP study facilities for horses cultured fish

16. Japanese efforts to increase availability of MUMS • Subsidy system for outsourcing of studies to obtain required data for MUMS application to third parties (e.g. research institutes) • Pharmaceutical companies can use these data for MUMS application

17. Japanese efforts to increase availability of MUMS Some cases of drug approvals based on subsidized studies: e.g. Drugs for Honeybees, Horses, and Vaccines for Cultured fish

18. Japanese Perspective Efforts including international harmonization to increase the availability of MUMS should be strongly promoted Important for Veterinary Practice Animal Hygiene Food Safety Human Health

19. Conclusions • There are no legislative definitions of MUMS in JAPAN; • Needs for MUMS approval have been growing; • Efforts to increase availability of MUMS should be encouraged; • International harmonization concerning MUMS should be promoted.