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Anderson Mori & Tomotsune
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''...
Winston & Strawn LLP
As of March 2023, 143 products approved in the United States or European Union are not approved in Japan.
Anderson Mori & Tomotsune
On October 12, 2023, "Partial revision of guidelines regarding advertisements, etc. related to medical or dental practices, hospitals or clinics" (Medical Policy No. 1012 No. 1, Ministry of Health...
Anderson Mori & Tomotsune
本稿では、米国の連邦取引委員会...
Anderson Mori & Tomotsune
While Japanese law does not provide formal definitions of digital healthcare and digital medicine, there is a difference in those terms based on whether a product constitutes a "pharmaceutical" or a "medical device" ...
Kangxin
国家健康医療ビッグデータ研究院がこのほど...
Kangxin
国家健康医療ビッグデータ研究院がこのほど...
Hogan Lovells
It's been five years since both the name and the content of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (the "Act")
Jones Day
The Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field ("Next Generation Medical Infrastructure Act") ...
Crowe MacKay LLP
Japanese lawmakers are scheduled to submit a bill in the ongoing Parliamentary session that would amend the Health Promotion Law to completely ban smoking inside schools, hospitals and government offices.
Jones Day
The "Act Regarding Anonymized Medical Data to Contribute to R&D in the Medical Field" ("Next Generation Medical Infrastructure Act" or "Act") was enacted in Japan on April 28, 2017...
Jones Day
Due to the uncovering of clinical research misconduct in the past few years, the Clinical Research Act was enacted on April 7, 2017, and was promulgated on April 14, 2017.
Morrison & Foerster LLP
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.
Jones Day
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
After the pilot, the MHLW will hold a hearing to consider extending the program.
Jones Day
The Japanese government has established the Agency for Medical Research and Development ("AMED") to promote medical research and development more efficiently and comprehensively.
Jones Day
A material amendment to the law regulating drugs and medical devices in Japan has recently been implemented.
Day Pitney LLP
Konaka, a Japanese men’s clothing retailer and Phiten, a Japanese holistic products company announced their collaboration and introduction of "Konaka X Phiten Dress Shirt" on July 5, 2011.
Lovells
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. This
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