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Home » Topics » Regulatory » MHLW

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Pills and bottle

After years of effort, Japan slashes drug lag

Dec. 7, 2020
By Alfred Romann
TOKYO – Steadily over a decade and a half, Japan’s drugs and devices regulator has all but eliminated a huge drug lag that put the second largest drug market in the world well behind most others in terms of the time it took for approvals and patient access to innovative drugs.
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Cabometyx

Takeda wins additional indication for tyrosine kinase inhibitor Cabometyx

Dec. 3, 2020
By Gina Lee
HONG KONG – Takeda Pharmaceutical Co. Ltd. received approval from Japan’s Ministry of Health, Labor and Welfare (MHLW) for an additional indication for its tyrosine kinase inhibitor, Cabometyx (cabozantinib), clearing the firm to manufacture and market 20-mg and 60-mg tablets for patients with unresectable hepatocellular carcinoma that has progressed after prior systemic therapy.
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Approved stamp

Cureapp wins approval for Cureapp SC, Japan’s first therapeutic app

Sep. 4, 2020
By Gina Lee
HONG KONG – Tokyo-based Cureapp Inc. has received the Ministry of Health, Labour and Welfare (MHLW)’s green light to manufacture and sell Cureapp SC [Smoking Cessation] Nicotine Addiction Treatment App and CO Checker, its therapeutics app to aid patients who are quitting smoking.
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Japanese flag

Japan’s MLWH ends June with string of approvals, looks set for busy 2H 2020

July 7, 2020
By Gina Lee
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
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Japan’s MLWH ends June with string of approvals, looks set for busy 2H 2020

July 2, 2020
By Gina Lee
HONG KONG – Japan’s Ministry of Health, Labour and Welfare (MHLW) ended the first half of 2020 by handing out a flurry of approvals to both domestic and international companies across a wide spectrum of indications.
Read More
Japanese shield and coronavirus

Japan advances fight against COVID-19 with four-day approval for remdesivir

May 12, 2020
By David Ho and Gina Lee
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
Read More
Japanese shield and coronavirus

Japan advances fight against COVID-19 with four-day approval for remdesivir

May 8, 2020
By Alfred Romann and Gina Lee
HONG KONG – Japan has become the first country in the world to approve Veklury (remdesivir), Gilead Sciences Inc.’s experimental drug, to treat COVID-19. The fast approval was based on U.S. data and that country’s emergency use of the drug to tackle the pandemic, although it is unclear whether the drug is safe or effective for treating COVID-19.
Read More
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