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Enforcement Of The Next Generation Medical Infrastructure Act
The Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field ("Next Generation Medical Infrastructure Act") ...
Jones Day
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Japan Joins Medical Devices Single Audit Program Pilot
Last month, the Ministry of Health, Labor and Welfare of Japan officially announced it will join the Medical Devices Single Audit Program ("MDSAP") Pilot.Jones Day - Article
Takeda Pharmaceuticals Trying To Buy Shire To Replace Fading IP
Takeda Pharmaceuticals, ranked in the top 20 pharmaceutical companies in the world in sales, is seeking to grow its technological base with a merger by a $64 billion purchase of Ireland's Shire.Keisen Associates - Article
Japan Begins Pilot Program For Accelerating Innovative Drugs Initially Developed In Japan
After the pilot, the MHLW will hold a hearing to consider extending the program.Jones Day - Article
Life Science Newsletter (January 2025)
Newsletter "Life Science Newsletter (January 2025)" has been published. Contents 1. Release of Summary Report on the Amendments to the Pharmaceuticals Act 1.1 Reinforcement of Quality Assurance.Anderson Mori & Tomotsune - Article
Innovative 3D Printing In Healthcare: From Design To Drug Delivery
The latest advancements in Additive Manufacturing (AM) or 3D printing technology represent a remarkable breakthrough in the pharmaceutical sector. From diagnostics to drug delivery, 3D printing is empowering.Marks & Clerk - Article
Updates On Drug Regulations In Japan – Reducing Barriers To Entry For Drug Companies Entering The Japanese Market
As of March 2023, 143 products approved in the United States or European Union are not approved in Japan.Winston Taylor - Article
Japan's MHLW Highlights Four Key Themes In Pharmaceuticals And Medical Devices Act Timeline Amendment
On September 12, 2024, the Pharmaceutical and Medical Device System Subcommittee (the "Subcommittee") of the Japanese Ministry of Health, Labor and Welfare ("MHLW")...Ropes & Gray LLP - Article
The BIOSECURE Act Becomes Law
On December 18, 2025, President Trump signed into law the BIOSECURE Act as part of the National Defense Authorization Act (NDAA), which is the U.S. Congress's annual defense policy bill.Morrison Foerster - Article
Japan's AMED Offers 'Double Match Up' Grants For Pharma Startups: Considerations For Investors And Companies
The Japanese government is aware of the challenges in securing funds for drug development within Japan's biopharmaceutical startup ecosystem, especially compared to Europe and the United States.Greenberg Traurig - Article
テクノロジー満載なロボットレストラン、今後のトレンドになるか
人工知能（AI）業界の発展が近年、注目を浴びている。Kangxin - Article
The BIOSECURE Act Becomes Law (Japanese)
2025年12月18日、トランプ大統領は...Morrison Foerster - Article
Request For Public Comments On The Revised Draft "Guidelines For Distribution Stakeholders To Adhere To For Improving The Distribution Of Medical Pharmaceuticals"
On January 15, 2020, the Ministry of Health, Labor and Welfare announced the ``Guidelines that distribution personnel should follow to improve the distribution of medical drugs''...Anderson Mori & Tomotsune - Article
Publication Of The "Casebook On Antimonopoly Law For Industrial Structural Reform To Ensure Stable Supply Of Generic Drugs"
On February 17, 2025, the Ministry of Health, Labour and Welfare ("MHLW") and the Japan Fair Trade Commission ("JFTC") published the Casebook on Antimonopoly Law for Industrial Structural Reform...Anderson Mori & Tomotsune - Article
Life Science Newsletter April 2025
The Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Economy, Trade and Industry (METI) have revised the Guidelines for New Business Activities in the Healthy Life Extension Industry Sector...Anderson Mori & Tomotsune - Article
Amendment To Drugs And Medical Devices Law In Japan Takes Effect
A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented.Jones Day - Article
New Regulations On Clinical Research
On April 7, 2017, the 193rd Diet of Japan passed a legislation regarding clinical researches – this "Law on Clinical Research (rinsho kenkyu hou)" will come into effect within one year.Morrison Foerster - Article
Key Regulatory Considerations For Pharmaceuticals And Medical Devices In Japan
Japan's healthcare market is undergoing a significant transformation driven by an aging population and technological innovation.
Oh-Ebashi LPC & Partners - Article
The Patentability of Medicinal Inventions Related to Personalised Medicine in Japan
As the difficulties in producing new chemical entities continue for pharmaceutical companies, their research strategies have recently emphasised not only the development of new medicines, but also life cycle management. ThisLovells - Article
Change In JPO's Examination Practice For Use-Limited Food/Drink Inventions
The JPO has announced that it will allow patenting of food/drink inventions characterized by their novel use applications (use-limited food/drink invention) based on its newly-revised Examination Guidelines...Seiwa Patent & Law
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