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.
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
Kissei Pharmaceutical Co. Ltd. has withdrawn its NDA in Japan for rovatirelin (KPS-0373) for the treatment of spinocerebellar degeneration. Kissei, of Osaka, Japan, said it temporarily withdrew the application for marketing approval and would discuss the possibility of conducting additional clinical trials with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), because the PMDA expressed concern about the approval based on the current clinical trial data.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
Japan’s Pharmaceutical and Medical Devices Agency has cleared Healios K.K. and Sumitomo Pharma Co. Ltd. to begin a phase I/II study of HLCR-011, which is composed of retinal pigment epithelial (RPE) cells derived from allogeneic induced pluripotent stem cells (iPS) in patients with RPE tear.
TOKYO – Japan’s Pharmaceuticals and Medical Device Agency (PMDA) is refocusing its efforts to strengthen ties with Asian counterparts as COVID-19 and market trends show a clear need for faster drug development, approval and accommodation for ailments more common in the region.
TOKYO – Japan’s Pharmaceuticals and Medical Device Agency (PMDA) is refocusing its efforts to strengthen ties with Asian counterparts as COVID-19 and market trends show a clear need for faster drug development, approval and accommodation for ailments more common in the region.
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.
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