Fujifilm Holdings Corp. has bagged the Japanese Pharmaceuticals and Medical Devices Agency (PMDA)’s approval for CXR-AID, its artificial intelligence (AI) powered chest X-ray analysis system developed in collaboration with Lunit Inc.
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.
Rapid changes, a traditionally conservative approach and a chronic lack of regulatory transparency could undo a lot of the progress that Japan has made in the past few years to speed up approvals and all but eliminate a punishing drug lag that, for decades, held back the development of the country’s biopharma sector.
Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has been stepping up efforts to bring innovative medical devices to market faster and make the regulatory approval process more predictable and further speed up approval processes that have been known for long delays.
With 10 cases of serious shock and anaphylaxis, including one death, in the month since Seikagaku Corp.’s osteoarthritis drug, Joyclu (diclofenac etalhyaluronate sodium), launched in Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) issued a blue letter to health care professionals and is adding a warning section to the drug’s Japanese label.
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.
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.
HONG KONG – Aiming to increase the financial stability of the national health care insurance system, Japan has announced a list of 17 drugs for which prices will be reduced. The country’s Central Social Insurance Medical Council, an advisory group from the Ministry of Health, Labour and Welfare (MHLW), approved the drug repricing system on Jan. 22.
HONG KONG – Aiming to increase the financial stability of the national health care insurance system, Japan has announced a list of 17 drugs for which prices will be reduced.
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