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Home » Topics » Regulatory » MHLW

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Japanese money and medicine

Japan’s annual drug price reforms result in less predictability for pharma market

April 19, 2022
By Tamra Sami
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
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Japanese money and medicine

Japan’s annual drug price reforms result in less predictability for pharma market

April 18, 2022
By Tamra Sami
Japan’s Ministry of Health, Labour and Welfare announced 2022 drug price revisions that became effective on April 1. Across the board, the cuts averaged about 6.6%, which translates to more than ¥600 billion (US$4.73 billion), and the pace of cuts is expected to accelerate. Price cuts in 2021 were worth roughly ¥430 billion.
Read More

Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 5, 2022
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021.
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Japan rolls out higher than average 32 approvals in March to close out fiscal year

April 4, 2022
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare finished the first quarter – and Japan’s fiscal year – with a bang, handing out 32 approvals in the month of March. It marked a massive jump from previous months, which saw 13 products approved in February 2022 and 12 in January 2022. A total of nine products were approved in December 2021.
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Green approved stamp

Sanofi’s Xenpozyme becomes first therapy approved for rare progressive genetic disorder ASMD

March 29, 2022
By David Ho
Sanofi SA’s enzyme replacement therapy, Xenpozyme (olipudase alfa), has been approved for use in Japan, making it the world’s first and only approved therapy to treat acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick type B disease. Sanofi’s executive vice president and global head of R&D, John Reed, hailed it as a “watershed moment” that was the culmination of 20 years of research.
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Keita Mori, CEO, Sanbio

Japan’s Sanbio submits BLA for brain injury regenerative therapy under Sakigake designation system

March 29, 2022
By Tamra Sami
Regenerative medicine company Sanbio Co. Ltd. submitted its BLA for its lead mesenchymal stem cell-based treatment, SB-623, to Japan’s Ministry of Health, Labour and Welfare for chronic motor deficit due to traumatic brain injury. The application was submitted through Japan’s Sakigake designation system.
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Digital 3-D illustration of Japan's flag, light effects

Japan updates guidelines for cybersecurity, single-use devices and MDSAP

Feb. 24, 2022
By David Ho and Gina Lee
Japan’s Ministry of Health, Labor and Welfare (MHLW) released a number of new guidelines and clarifications on medical device regulatory issues including cybersecurity, remanufactured single-use devices (SUDs) and the Medical Device Single Audit Program (MDSAP).
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Abdominal pain illustration

Takeda’s Alofisel becomes Japan’s first approved allogeneic stem cell therapy with Crohn’s disease nod

Oct. 5, 2021
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
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Abdominal pain illustration

Takeda’s Alofisel becomes Japan’s first approved allogeneic stem cell therapy with Crohn’s disease nod

Sep. 29, 2021
By Gina Lee
Japan’s Ministry of Health, Labour and Welfare approved Takeda Pharmaceutical Co. Ltd.’s Alofisel (darvadstrocel) to treat complex perianal fistulas in patients with non-active or mildly active luminal Crohn’s disease. This marks the first allogeneic stem cell therapy to be greenlighted in the country.
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Padcev vial

Astellas and Seagen win Japanese approval for Padcev in advanced urothelial cancer

Sep. 28, 2021
By David Ho
Astellas Pharma Inc. and Seagen Inc. received approval through a priority review from Japan's Ministry of Health, Labour and Welfare for Padcev (enfortumab vedotin) to treat radically unresectable urothelial carcinoma that has progressed after chemotherapy. The green light for the antibody-drug conjugate is based on the global phase III EV-301 clinical trial, which included sites in Japan.
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