Mums perspective of japanese situation
Download
1 / 19

MUMS- Perspective of Japanese Situation - PowerPoint PPT Presentation


  • 333 Views
  • Uploaded on

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.

loader
I am the owner, or an agent authorized to act on behalf of the owner, of the copyrighted work described.
capcha
Download Presentation

PowerPoint Slideshow about 'MUMS- Perspective of Japanese Situation ' - ryanadan


An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -
Presentation Transcript
Mums perspective of japanese situation l.jpg

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 l.jpg
Japanese Background Increasing Interest in MUMS

  • Eating habits have become diversified.

  • Increasing needs for healthful diets.


Japanese background increasing interest in mums3 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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.


Japanese situation of minor species animals7 l.jpg
Japanese Situation of Minor Species Animals

Honeybees

(Horses)

minor?

Sheep


Japanese situation of minor species animals8 l.jpg
Japanese Situation of Minor Species Animals

Emu

Ostrich

Geese

Deer


Approved animal drugs more than 4 000 in japan l.jpg
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 l.jpg
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 l.jpg

Japanese Situation

Shortage of MUMS

Limited therapeutic, preventive and diagnostic options

Potential problems concerning

animal hygiene, veterinary practice

and human health


Japanese situation l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg
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 l.jpg

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 l.jpg
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 l.jpg
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.


ad