# Presentation: 224983

## 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.**
**Increasing needs for healthful diets.**
** **

## 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**
**   **
**  **

## 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

**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 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 Animals

- (Horses)
-  minor?

- Honeybees

-      Sheep

## Japanese Situation  of Minor  Species Animals

- Ostrich

- Deer

- Emu

- Geese

## 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

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

## Shortage of MUMS

Limited therapeutic, preventive and diagnostic options

Potential problems concerning 
animal hygiene, veterinary practice
and human health

**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 and**** ****animal hygiene**

## 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

**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 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 

**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 **

## Japanese efforts to increase availability of MUMS 

**e.g. Drugs for Honeybees, Horses, and Vaccines for Cultured fish**

**Japanese efforts to increase availability of MUMS **

**Some cases of drug approvals based on subsidized studies: **

## 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

**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.**