• Regulatory NewsRegulatory News

    Convergence: How to navigate the US-Japan 'Harmonization by Doing' program

    Regulators from the US Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) discussed how medical device sponsors can get approval for global studies accepted into the regulators’ joint “harmonization by doing” (HBD) program.   The program is designed to save development time and costs in developing life-saving cardiovascular devices through the simultaneous review of global studies, explained Shin Iwamoto, a PMDA principal r...
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    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...
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    3D Bio-Printed Products: ICMRA Members Discuss Potential Regulatory Frameworks

    As part of a project on emerging technologies, six regulators involved in the International Coalition of Medicines Regulatory Authorities (ICMRA) recently published a case study delving into the challenges of regulating 3D bio-printed products. In this hypothetical case, the regulators evaluated 3D bio-printed knee meniscus tissue and discussed how they would tackle similar products. The case study was conducted by Australia’s Therapeutic Goods Administration (TGA), Bra...
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    EU, Japan to Share More Information on GMP Inspections

    The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan. The agreement follows the exchange of letters on 13 September 2016 in which Japan’s Pharmaceutical Safety and Environmental Health Bureau of ...
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    Asia Regulatory Roundup: Drug Safety, Traceability at Forefront of China’s Health Reform Plan (16 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Puts Drug Safety and Traceability at Forefront of Healthcare Reform Program China has committed to bolstering the safety controls and traceability requirements that cover its local drug market. The commitment, which was made at a meeting of the State Council, is part of a raft of healthcare reform initiatives that are collectively intended to lessen China’s reliance ...
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    Asia Regulatory Roundup: China Looks to End Regional Variation in Trial Oversight (22 December 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. China Pushes to End Regional Variation in Strength of Clinical Trial Oversight The China Food and Drug Administration (CFDA) has committed to ending region-to-region variation in the strength of clinical trial oversight as it’s found that some regions are failing to comply with the more rigorous approach to clinical trial inspections and data quality. CFDA began its clam...
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    MDSAP to Continue Past Pilot Phase in 2016

    Put simply, the Medical Device Single Audit Program (MDSAP) isn't going anywhere when its pilot project ends in 2016, Kim Trautman, associate director, international affairs of the Office of the Center Director of CDRH at the US Food and Drug Administration (FDA), told attendees of RAPS' Regulatory Convergence on Wednesday. MDSAP is the international consortium of five regulators from the US, Australia, Japan (which came on board in June), Brazil and Canada looking to tr...
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    ICH Makes Organizational Changes

    The International Conference on Harmonisation (ICH) has renamed itself as the International Council for Harmonisation (ICH) and has now become a legal entity under Swiss law. ICH says its changes will help it to expand its membership, which currently includes pharmaceutical regulators from the US, EU, Japan, Canada and Switzerland. "More involvement from regulators around the world is welcomed and expected … This is matched by the possibility of wider inclusion of glob...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: China to Strengthen Oversight of Medical Device Manufacturing (13 October 2015)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Details New Approach to Medical Device GMP in Four Guidance Documents China Food and Drug Administration (CFDA) has moved to strengthen its oversight of medical device manufacturing. The new approach is detailed in four guidance documents covering medical device good manufacturing practices (GMPs), in which CFDA explains its approach to on-site inspections. CFDA...
  • 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...
  • FDA Blows Away Rivals in Approving Cancer Therapies

    The public persona of the US Food and Drug Administration (FDA) can ordinarily be described in a word: reserved. Its press releases frequently reveal an agency which hedges its statements, avoids hyperbole, and mostly steers clear of speculation. But every now and again, it feels like bragging a bit. Regulatory Braggadocio Specifically, it feels like bragging about how it compares to its foreign regulatory counterparts like the European Medicines Agency (EMA). While th...