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MUMS- Perspective of Japanese Situation . Tatsuro Sekiya, DVM   National Veterinary Assay Laboratory The Ministry of Agriculture, Forestry and Fisheries of Japan. Japanese Background Increasing Interest in MUMS . Eating habits have become diversified.

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mums perspective of japanese situation

MUMS- Perspective of Japanese Situation

TatsuroSekiya, DVM  

National Veterinary Assay Laboratory

The Ministry of Agriculture, Forestry and Fisheries of Japan

japanese background increasing interest in mums
Japanese Background Increasing Interest in MUMS
  • Eating habits have become diversified.
  • Increasing needs for healthful diets.
japanese background increasing interest in mums3
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
slide4
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

japanese situation of minor species animals
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

japanese situation of minor species animals6
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.

approved animal drugs more than 4 000 in japan
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.

japanese situation of minor use
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)

slide11

Japanese Situation

Shortage of MUMS

Limited therapeutic, preventive and diagnostic options

Potential problems concerning

animal hygiene, veterinary practice

and human health

japanese situation
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

slide13
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
japanese regulatory requirements
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
japanese situation15
Japanese Situation

Difficulty to perform studies required for the application for approval

Limited availability of GLP study facilities

for

horses

cultured fish

japanese efforts to increase availability of mums
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
slide17

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

japanese perspective
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

conclusions
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.
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