PMDA

Why many global drugs never reach Japan

Tue, 03 Feb 2026 12:00:00 -0500

For years, Japan’s “drug lag” was shorthand for slow regulatory reviews and delayed approvals compared with the U.S. and Europe. But even as regulatory timelines have shortened, review capacity has expanded and international alignment has improved, Japanese patients still face gaps in access to innovative drugs.

Why many global drugs never reach Japan

Thu, 29 Jan 2026 12:00:00 -0500

F.Med redefines the future of microsurgical robotics

Wed, 21 Jan 2026 11:00:00 -0500

Microsurgery is performed to connect small human vessels, but the technical difficulty required to conduct this type of surgery is quite specialized and limits the number of surgeons who can perform microsurgery.

Rakuten closes $100M series F round, teams with Lotte Biologics

Tue, 20 Jan 2026 11:00:00 -0500

Rakuten Medical Inc. raised $100 million in a series F round to support late-stage clinical development of ASP-1929, its Alluminox-derived photoimmunotherapy being tested with Keytruda (pembrolizumab) as a first-line treatment for recurrent head and neck cancer.

PMDA makes case for Japan as a haven for innovation

Wed, 15 Oct 2025 12:00:00 -0400

Japan has long been one of the premier markets for medical technology, but this market has suffered from a reputation for slow adoption of technologies outside the cardiovascular device space, a problem the Pharmaceuticals and Medical Devices Agency is keen to address.

Real-world data illuminates Rakuten's Alluminox solid tumor platform

Fri, 26 Sep 2025 10:00:00 -0400

Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.

PMDA more open to use of clinical data from other nations

Tue, 23 Sep 2025 12:00:00 -0400

Japan’s Pharmaceuticals and Medical Devices Agency has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.

PMDA more open to use of clinical data from other nations

Tue, 16 Sep 2025 12:00:00 -0400

Healios posts more upbeat data on Multistem cell therapy for ARDS

Tue, 18 Mar 2025 11:00:00 -0400

Latest findings on Healios K.K.’s stem cell therapy to treat acute respiratory distress syndrome (ARDS), coined Multistem (invimestrocel; HLCM-051), found the regenerative medicine effective in reducing the number of patient days on ventilator treatment, as well as mortality benefits.

Healios posts more upbeat data on Multistem cell therapy for ARDS

Fri, 14 Mar 2025 11:00:00 -0400

Dimerix licenses phase III kidney disease drug to Fuso for ¥10.5B

Tue, 07 Jan 2025 12:00:00 -0500

Dimerix Ltd. and Fuso Pharmaceutical Industries Ltd. signed a license agreement for the development and commercialization of Dimerix’s phase III candidate, DMX-200, for the treatment of focal segmental glomerulosclerosis in Japan for ¥10.5 billion (US$66.5 million) plus royalties.

Report: Drug regulators enabling forced labor in supply chain

Tue, 05 Nov 2024 12:00:00 -0500

Drug regulators around the world have a unique opportunity – and, in some cases, a legal mandate – to remove the taint of forced labor from the biopharma supply chain. But some of them, including the U.S. FDA and Japan’s PMDA, may be turning a blind eye to those responsibilities, according to a recent report from the nonprofit Centers for Advanced Defense Studies.

Japan PMDA opens second overseas office in Washington

Tue, 05 Nov 2024 12:00:00 -0500

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) set up its second overseas regulatory office in Washington, four months after the drug and med-tech regulator opened its first Asia base in Bangkok, Thailand, in July 2024.

Medipal and JCR move JR-446 toward clinic in Japan for mucopolysaccharidosis type IIIB

Tue, 02 Jul 2024 09:00:00 -0400

Medipal Holdings Corp. and JCR Pharmaceuticals Co. Ltd. have announced the completion of the clinical trial notification review by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for a phase I/II study of JR-446 for the treatment of mucopolysaccharidosis type IIIB (MPS IIIB; Sanfilippo syndrome type B).

Japan’s PMDA sees a role for e-consent in clinical trials

Mon, 11 Sep 2023 09:00:00 -0400

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 withdraws NDA for rovatirelin for spinocerebellar degeneration in Japan

Tue, 25 Jul 2023 12:00:00 -0400

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 withdraws NDA for rovatirelin for spinocerebellar degeneration in Japan

Fri, 21 Jul 2023 12:00:00 -0400

Healios, Sumitomo begin phase I/II trial of allogeneic iPS cells in retinal pigment epithelium tears

Tue, 27 Jun 2023 12:00:00 -0400

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.

Healios, Sumitomo begin phase I/II trial of allogeneic iPS cells in retinal pigment epithelium tears

Fri, 23 Jun 2023 12:00:00 -0400

Japan keen to deepen regional partnerships, says PMDA head

Tue, 01 Feb 2022 12:00:00 -0500

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.

Japan keen to deepen regional partnerships, says PMDA head

Wed, 26 Jan 2022 12:00:00 -0500

Fujifilm, Lunit get nod for collaborative AI-powered chest X-ray analysis system in Japan

Fri, 20 Aug 2021 13:00:00 -0400

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.

Japan’s volatile policy direction continues as challenge, but R&D remains strong

Tue, 03 Aug 2021 12:10:00 -0400

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 volatile policy direction continues as challenge, but R&D remains strong

Fri, 30 Jul 2021 12:00:00 -0400

PMDA moves to speed up approvals of innovative devices, improve predictability

Wed, 16 Jun 2021 13:00:00 -0400

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.

PMDA warns of shock, anaphylaxis with Joyclu

Tue, 01 Jun 2021 12:00:00 -0400

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.

After years of effort, Japan slashes drug lag

Tue, 08 Dec 2020 12:00:00 -0500

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.

After years of effort, Japan slashes drug lag

Mon, 07 Dec 2020 12:00:00 -0500

Japan’s drug repricing plan to hit some top sellers

Tue, 04 Feb 2020 12:33:00 -0500

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.

Japan’s drug repricing plan to hit some top sellers

Mon, 03 Feb 2020 12:00:00 -0500

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.