South Korea’s Ministry of Food and Drug Safety signed a confidentiality agreement with Japan’s Ministry of Health, Labour and Welfare and Pharmaceuticals and Medical Devices Agency to boost bilateral regulatory cooperation in the field of medical devices.
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) has jumped on board the e-consent train for clinical trials, publishing a guidance for the use of electronic means for obtaining a study participant’s informed consent.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
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.
The latest global regulatory news, changes and updates affecting biopharma, including: ICER cost models going global; Canada prepares for ICH Q12; HHS partners on Lyme innovation.
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.
