• Regulatory NewsRegulatory News

    Convergence: First-year experience with Japan’s amended medical device rules

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is providing priority review for certain innovative medical devices and has implemented a post approval change management process to allow for continuous improvement of medical devices.   The changes are part of the Amendment of the Pharmaceutical and Medical Device Act (PMD Act), which was implemented in September 2020. Officials from Japan’s Ministry of Health, Labour and Welfare (MHLW) and the PMDA provided a...
  • Regulatory NewsRegulatory News

    Key regulators featured in RAPS Convergence 2021 health authority forums

    On Monday, RAPS Convergence 2021 attendees will have the opportunity to hear from global regulators during three health authority forums. The presentations will highlight key topics and updates relevant to each regulatory body in hour-long sessions.   The session featuring Japan’s Pharmaceutical and Medical Devices Agency (PMDA) features four Japanese regulators, including session leader Tetsuya Kusakabe, PMDA’s international coordination officer, and Kanako Sasaki, de...
  • Feature ArticlesFeature Articles

    Regulation of cell and gene therapy products in Japan

    In recent years, new cell and gene therapies have been developed and approved in a number of countries, including Japan. The Japanese government fully supports academia and the pharmaceutical industry in the research and development of these innovative therapies, and in 2019, revised the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices to enact the conditional early approval system for accelerating the development and ...
  • Regulatory NewsRegulatory News

    ATMPs: Global regulators eye harmonization for ultra-orphan products

    Top regulators from the US, EU, UK and Japan view harmonization as a critical factor in enabling the development of advanced therapy medicinal products (ATMPs) for ultra-rare diseases.   Particularly for cell and gene therapies targeting patient populations numbering in the hundreds worldwide, commercial viability and the feasibility of clinical trials can be complicated by jurisdictional differences in regulatory requirements. Such challenges were the topic of convers...
  • Feature ArticlesFeature Articles

    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
  • RoundupsRoundups

    Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.   PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect ...
  • Feature ArticlesFeature Articles

    PMDA Consultation in Japan

    This article focuses on PMDA consultations for drug development. Japan's Pharmaceuticals and Medical Devices Agency (PMDA) was established by the Ministry of Health, Labour, and Welfare (MHLW) in 2004. In addition to scientific reviews and conformity audits of marketing authorization applications for drugs and medical devices, PMDA provides various types of consultations, from pharmaceutical affairs on research and development strategy to clinical trials. It is valuabl...
  • Regulatory NewsRegulatory News

    Major Changes to Medical Device Registration Process in Japan

    Content provided by Emergo Group , a medical device regulatory affairs and quality assurance consulting firm with offices worldwide. Revised medical device registration and approval requirements in Japan will become law 25 November 2014 and will impact several compliance areas for foreign manufactures active in the market, according to Emergo’s Tokyo office. Replacing the Pharmaceutical Affairs Law (PAL), the Pharmaceutical and Medical Device Law (PMDL) will ...