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Presentations at Animal Health Innovation Asia 2021

Animal Health Innovation Asia 2021 will be held from October 19th to 20th, sponsored by Kisaco Research. We, AHRMS, have been cooperating in program setting as a Consulting Partner for 3 years.

This time, I am planning to give presentation regarding the market status in Jpan and how to obtain marketing approvals for veterinary medical devices and veterinary in-vitro diagnostic drugs. You can watch it on demand at any time. We hope it will be of help to you.

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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.

https://www.japantimes.co.jp/news/2021/09/04/national/politics-diplomacy/suga-quits-coronavirus-undoing/

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)

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New Application Templates by JMAFF

With the revision of the Pharmaceuticals and Medical Devices Act (PMD Act) on August 1, 2021, some procedures for the pharmaceutical system of manufacturing and marketing of veterinary drugs, etc. have been changed.

Some application forms for manufacturing, manufacturing and marketing, foreign manufacturer accreditation for veterinary drugs, veterinary medical devices, in vitro diagnostic kits, etc. have been partially changed. Please be careful.

https://www.maff.go.jp/j/syouan/tikusui/yakuzi/y_gyokyoka/forms.html

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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:

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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.

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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

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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.

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