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U.S. Department of Health and Human Services

Animal & Veterinary

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MUMS - Japanese Perspective

Dr. Tatsuro Sekiya

DR. SEKIYA:  Thank you.  Thank you, Dr. Craigmill, and good morning, ladies and gentlemen.  Today I will try to present here about MUMS in Japan.  First I would like to introduce to the background of MUMS situation in Japan.  Then I would like to talk about the current status of MUMS approval and finally about the issue for the future.
  (Slide.)

Also in Japan, MUMS has been attracting attention increasingly, and there are some background for the situation.  Firstly, I would like to point out diversification of dietary lifestyles and eating habits of Japanese in recent years.  Individual dietary preferences and the eating habits have been changing.  Therefore, it is necessary for livestock farmers to raise various kinds of animal species for food products to fulfill the consumers needs.  Under the circumstance, consciousness towards healthful diets becomes particularly stronger.  For example, there are needs for the meat of less fat content for the reason of health.
  (Slide.)

With a higher standard of animal hygiene and veterinary practice in recent years, the kind of animal species --- to be applied have been extended, and this situation may be the factor for increasing interest in MUMS.  The growing awareness about animal welfare may also be a factor for the extension of the field of veterinary practice.  Furthermore, with regard to companion animals or pets, a great variety of species have begun to be raised.  Now it has become to be the subject of veterinary practice from rabbit or hamsters, to ornamental fish or reptiles.
(Slide.)

Well, under the background I mentioned to you in a previous slide the needs for MUMS have been certainly increasing.   However, I should say that pharmaceutical industries are reluctant to develop MUMS and to make efforts to get MUMS approval.  The reason for this is that enormous cost and time have to be invested for the development of MUMS and for getting approval.  For getting MUMS approval the requirement of verification of quality, efficacy, and safety of the drug by conduction of safety studies and clinical trials in compliance with GLP and GCP have been becoming more and more rigorous, and the current position, the organizations such as mergers and acquisitions are continually made among Japanese animal drug industries, including foreign affiliated companies.  With this situation, development of drugs such as MUMS with no great sales volume and profit can be expected after being marketed has become difficult from an economic viewpoint. 
  (Slide.)

Next I would like to talk about the situation of MUMS in Japan.  First, what is the definition of the wording, minor species and MUMS, in Japan?  There are no legislative clear definitions for them.  We judge it based on general interpretation  Animals other than major species animals can be regarded as minor species animals. 
  (Slide.)

Well, then what is the definition of major species animals?  Again, there are no legislative clear definitions for them.  When we judge it on the basis of raising head count, cattle, swine, chickens, cultured fish, dogs and cats can be categorized in it.  Therefore, although there are no clear definitions, animals other than cattle swine, chickens, cultured fish, and dogs and cats can be regarded as minor species animals in Japan.
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With regards to horses, I think it may be appropriate to categorize into minor species animals from the veterinary medical viewpoint because of the slowdown of the development of new drugs for horses in recent years.
  (Slide.)

Well, obviously minor species animals in Japan.  For example, ostrich, emu, deer, geese can be quoted.  The raising head counts of major species animals are thought to be 1,700,000 for dairy cattle, 2,800,000 for beef cattle, 9,000,000 for swine, and more than 10,000,000 for dogs.  However, for example, the raising head count of ostrich, about 10,000, and deer are around 5,000.  They are very small in number compared to those of the major species animals.  As for the other minor animals in Japan, ducks, turkeys, quails, guinea farms, pheasant and wild boars, et cetera, are raised for food production.
  (Slide.)

In Japan, more than 4,000 animal drugs have been approved.  Most of them have been approved for use in major species animals.  In contrast, very limited number of drugs have been approved for use in goat, sheep, honey bees, quail, turkeys, et cetera.  Also there are relatively old drugs approved for the use in horses.  A small number of new drugs for horses are available currently.  Only two drugs have been approved for the use of honey bees.  There are the animal species such as ostrich and deer to which no drug applications have been approved.
  (Slide.)

Next I would like to introduce you on the situation of minor use in Japan.  Like the minor species, there are no legislative clear definitions of minor use.  Generally speaking, it may be appropriate to regard the following as minor use drugs.  Namely, irrespective of the indicated animal species, such drugs for which there are little or inconstant demands because of a their incidence, or sporadic occurrence, or limited geographical occurrence of the indicated disease may be categorized as minor use drugs.  Vaccines which are important for animal hygiene and considered necessary to be prepared for just in case of the occurrence of a disease that does not occur ordinarily may be included in this category.
  (Slide.)

Well, under the background situation I talk about, the shortage in available MUMS will eventually lead to the limitation in therapeutic, preventive, and diagnostic options.  As a consequence, this may lead to the problem in animal hygiene and veterinary practice.  Furthermore, this may lead to the issue of human health.
  (Slide.)

Well, the situation of the shortage of MUMS will result in the increase of extra-label use of human drugs or drugs approved for other animal species.  This leads veterinarians to use drugs for which extra-label use is allowed, but the safety and the efficacy are not confirmed in the animal species that they are going to administer it.  Under the situation of the lack of the information on appropriate dosage, the veterinary practice has to be conducted relying on the skills of veterinarians.  In addition, when an extra-label use drug is administered to food-producing animals, the judgement of withdrawal period is set depending on the veterinarian’s skill and experience because nothing has been established on a scientific basis.  Therefore, it has been pointed out that this situation is not only the issue of animal hygiene and veterinary practice, but also the issue of food safety.
  (Slide.)

Well, as for the regulatory requirement for application for new animal drug approval under the pharmaceutical affairs law.  Safety studies, clinical trials, and residue studies should be conducted using the target animals, and the data shown in this slide should be submitted.
  (Slide.)

Well, for application for new drug approval, even though for MUMS, it is required to collect and submit the data obtained in compliance with the relevant regulations and guidelines as shown in the previous slide.  For the conduction of the studies to obtain the required data, enormous cost and time have to be invested.  However, there are no regulatory systems for animal drugs like the process of orphan drug approval for humans.
  (Slide.)

There are some problems or difficulty in conduction of the required studies for application.  For example, the limited number of facilities where GLP studies for horses or cultured fish can be conducted.  Like this, there are some factors other than the financial aspects limiting development and approval of MUMS.
  (Slide.)

Well, I would like to introduce you to the effort of Japanese regulatory authority to facilitate the development of MUMS and to increase the availability of approved MUMS under the circumstance of background and the current situation as I mentioned.  For instance, as shown in this slide, there is a subsidy system which the third-party research institute in place of pharmaceutical industries may conduct the required studies such as safety studies, clinical trials, and residue studies with a national grant; and the pharmaceutical industries can use the study data obtained by these studies for MUMS application.  Like this, some subsidy systems are available to reduce the costs for MUMS development and to stimulate the development will of pharmaceutical industries and to facilitate the MUMS approval.
  (Slide.)

For examples of the MUMS approval assisted by the similar national subsidy system, drugs for honey bees and horses and vaccines for cultured fish can be quoted.
  (Slide.)

Under the current situation, there are no available legislative and institutional frameworks to provide increase in MUMS other than the national subsidy system I mentioned previously.  Based on the background and the situations I talked so far, it is considered necessary to promote measures further to facilitate the MUMS development and approval, including international harmonization.  I believe that it will be important for veterinary practice and animal hygiene, food safety, and even human health.
  (Slide.)

Well, as a conclusion I would like to summarize my presentation.  In Japan, there are no legislative definitions for MUMS while the needs for so-called MUMS are increasing.  Therefore, appropriate countermeasures are necessary.  Thus, further efforts to increase availability of approved MUMS are encouraged.  As one of the measures for it, I believe that the promotion of international harmonization concerning MUMS is quite necessary.  Thank you very much for listening.
  (Applause.)

DR. CRAIGMILL:  Thank you very much, Dr. Sekiya.  Some of you may have noticed that we seem to be 10 minutes ahead of schedule.  Actually this -- and I don’t want any CVM reviewers to listen to this -- this was actually a mathematical mistake, and that really we were supposed to end at noon.  We are not 10 minutes ahead.  There was this -- believe me.  Trust me.  I’m from academia.
  (Laughter.)

DR. CRAIGMILL:  I’ve heard that one before.  Thanks very much.  We are actually exactly on schedule, and we will begin lunch at noon and again start promptly at 1:15.  Now it is my pleasure to introduce Professor Jorge Errecalde.  He is visiting today from the University of La Plata in Argentina where he is a professor of pharmacology, another pharmacologist; we are always happy to see them.  He is a fellow of the AAVPT, the American Association of Veterinary Pharmacology and Therapeutics.  He is also an honorary member of the European College of Veterinary Pharmacology and Toxicology.  He serves on the JVPT editorial board as several other people in this room do as well.  He is a veterinarian, again with a doctorate, and he wears two hats.  So today we are not sure which one he has got on, but he also serves as the president of INCAM SA, a company which does contract research, I presume for drug approvals.  So, Professor Errecalde, thank you for coming.