The Ministry of Agriculture, Forestry and Fisheries has notified prefectural governments and the Japan Veterinary Medical Association of standards for appropriately conducting clinical research on veterinary drugs that do not violate the Pharmaceutical Affairs Law.
“Clinical research on animal pharmaceuticals, first rule setting by the government” の続きを読むA part of our video presentation became an article on IHS Markit.
Dr. Yuki Ujimasa, DVM, MS, President of AHRMS, Inc., gave a presentation entitled “Regulatory Pathways and Market Insights in Japan” at Animal Health Innovation Asia 2021 held on October 19-20, and Mr. Joseph Harvey, Editor of IHS Markit, picked up a part of the presentation and introduced it as an article.
New Minister of AFF will be determined on Sep. 30th, 2021.
Prime Minister Suga has decided not to run for the presidential election, so a new prime minister will be elected on September 29th.
Since the Cabinet will be formed by the new Prime Minister, it is expected that the new Minister of Agriculture, Forestry and Fisheries will be decided on September 30th.
Therefore, companies planning to apply to the MAFF should be aware that the minister’s name must be changed depending on whether the application is filed within September or the application is delayed in October.
Caution! Minister of Agriculture may be changed due to reshuffle of the Cabinet next week
When we file NADA, ANADA, FMA or any other applications, we are required to correctly write the current minister’s name of MAFF (Ministry of Agriculture, Forestry and Fisheries) on the application cover letter.
According to a breaking news today, Mr. Suga, Prime Minister, is planning to reshuffle the cabinet next week. It means that the minister of agriculture may be changed from Mr. Nogami to someone.
We have to pay attention to it because we don’t want to correct our application letter.
In fact, we are planning to file an application and decide to do it within this week.
https://mainichi.jp/articles/20210831/k00/00m/010/347000c
(Sorry! this article is written in Japanese)
2020 Global Benchmarking Survey Overview Report
The HealthforAnimals Global Benchmarking Survey is run every 5 years and has now grown to include 11 countries in the 2020 survey. The purpose is to examine the interactions between industry and regulatory systems for veterinary medicinal products, particularly the impact of regulations on the animal health industry’s ability to access markets, be innovative, continue to commercialise existing products and be competitive.
You can download the report below:
AHRMS’s recent D-MAH Achievement
One of our main activities is to work as Designated Marketing Authorization Holder (D-MAH) for foreign animal health manufacturers that don’t have any subsidiaries in Japan.
According to JMAFF’s product database, AHRMS received a needle free injector for pigs as D-MAH on Feb. 8, 2021.
https://www.vm.nval.go.jp/public/detail/18635 (Sorry in Japanese)
Senju Pharmaceutical launched “IDU Senju®” eye drops for feleine herpesvirus through DS Pharma Animal Health.
Osaka-based Senju Pharmaceutical Co., Ltd. (Headquarters: Chuo-ku, Osaka, President: Shuhei Yoshida, hereinafter “Senju Pharmaceutical”) and DS Pharma Animal Health Co., Ltd. will release “IDU Senju (R) “, an eye drops for cat herpesvirus infections, which Senju Pharmaceutical obtained marketing approval in December 2020, and will release it on May 19, 2021.
“Senju Pharmaceutical launched “IDU Senju®” eye drops for feleine herpesvirus through DS Pharma Animal Health.” の続きを読むDS Pharma Animal Health Announces World’s First Marketing Authorization Approval for a Canine Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cell Product, Stemcure®
DS Pharma Animal Health Co., Ltd. (Head Office: Chuo-ku, Osaka, Japan; President & CEO: Kazuhiro Takada) announced today that it received marketing authorization on March 19 for Stemcure® (development code: A-110), a canine allogeneic adipose tissue-derived mesenchymal stem cell product that is classified as a veterinary regenerative medical product (animal somatic stem cell-processed product). This is the world’s first authorization approval for the manufacture and marketing of a veterinary regenerative medical product whose main ingredient is canine allogeneic adipose tissue-derived mesenchymal stem cells.
You can download the press release from the link below:
https://animal.ds-pharma.co.jp/html/english/pdf/press_210322b.pdf
Animal Health Innovation Asia 2020
We succesfully had a virtual event of Animal Health Innovation Asia 2020 by Kisaco Research. November 25th was Japan Day, and thanks to Mr. Calan Smith, I was honored to host 3 programs, i.e. “Panel Discussion” by Messrs. Kato, Fukui and Hagihara who are industry leaders from Zoetis Japan, Zenoaq, and Kyoritsu Seiyaku, respectively, “Innovation Showcase” by 4 start-ups, such as Toletta Cats, MT3, Vetamic (Nihon Univ.), and KAICO, and “University Pavilion” by 3 universities, such as Prof. Mizuno of Yamaguchi Univ., Assoc. Prof. Isaka of Rakuno Gakuen Univ., and Dr. Kato of Tokyo Univ. of Marine Science and Technology.
We hope that we can have an offline event, not a virtual one, in Tokyo in 2021.
Introduction of AHRMS, Inc.
In advance for “Animal Health Innovation Asia 2020” by Kisaco Research, we prepared an introductory video 🙂
I hope it can be of help to your understanding of our company’s services.
- The program “Animal Health in Japan” on November 25th during “Animal Health Innovation Asia 2020”
- Corporate brochure:
- Regulatory Pathways and Market Access:
Animal Health Innovation 2020
Thanks to Kisaco Research, the two pre-events of Animal Health Innovation Asia 2020 were successfully conducted on November 3rd and 10th. According to Mr. Stephen Swarray of Kisaco, 300 people joined the pre-event “Next Steps for Animal Health in Asia” by Zoetis. Of course, I really enjoyed both, too.
