Contributing to Global Animal Health
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.
Crecon Research & Consulting has annual animal health seminar for the top managements of animal health manufacturers and dealers in Japan.
The 54th seminar will be held virtually on October 22, 2021.
Dr. Yuki Ujimasa, our president, will give a keynote lecture with the above captioned title, and We are very honored.
Genjiro Kaneko, picked as the new farm minister, is a veteran lawmaker dedicated to fostering local industries in rural areas.
“New farm minister Kaneko dedicated to fostering local industries” の続きを読む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.
“Presentations at Animal Health Innovation Asia 2021” の続きを読む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.
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)
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
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:
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)
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 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