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- PMDA Puts Regulatory Approval on a Fast Track - DIA Global Forum
To that end, PMDA has implemented various innovative, fast-track regulatory initiatives as part of its current 5-year Mid-Term Plan, including the sakigake Designation System and the most recent Conditional Early Approval System The result: PMDA scored a major success with the speedy approval of a “titanium bridge” (NPC-17) for type II thyroplasty – a device whose approval would have
- PMDA Opens the Door to Innovative Products in Japan
In a departure from their approach to previous PMDA Town Halls held at DIA Global Annual Meetings, at DIA 2024 this past June, leaders from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan invited sponsors and researchers to discover the benefits of developing innovative therapeutic products in Japan, based on Japanese market information and pharmaceutical regulation
- Sakigake System: From Pilot to Permanent Summary and Impact of . . .
This summary of the revision of Japan’s Pharmaceutical Affairs Act (PMD-Act) issued in December 2019 focuses on two of its three pillars and their impact on companies in Japan
- PMDA Town Hall - DIA Global Forum
In April 2019, PMDA welcomed its new chief executive, Yasuhiro Fujiwara, who has established four new priority areas (the “4 Firsts”) In addition, the Pharmaceuticals and Medical Devices (PMD) Act, the fundamental statute for pharmaceuticals and medical devices regulation in Japan, is under revision and deliberation in the Diet (the Japanese Parliament) The PMDA Town Hall at the Global
- The Philosophy and Pathway for Implementation of Regulatory Science in . . .
PMDA’s development work in regulatory science has aimed to fuse science and engineering into a new form of evaluation science (RS engineering) and to fully account for the need to establish common appropriate assessment methods for new drugs and devices that ensure rapid introduction when this is in the public interest, while also maximizing
- Utilizing Real World Data: A PMDA Perspective - DIA Global Forum
PMDA has utilized RWD for drug safety assessment since 2009 Recently, Japanese regulations were updated, including a publication of guidelines, for promoting RWD utilization by pharmaceutical industries in pharmacovigilance (Available here in Japanese only ) Several challenges have been identified in utilizing RWD for regulatory purposes, including data quality, data coding, deep
- Policies to Promote Development of AI-Based Medical Devices in Japan
The PMDA’s Scientific Committee published “ Issues and recommendations on AI-based medical diagnosis systems and medical devices,” which aimed to examine the characteristics and risks of AI-based medical devices and points to keep in mind when using them, and to help with regulatory review and consultation
- Regulatory Utilization of Real-World Data and Real-World Evidence in Japan
Real-world data (RWD) and real-world evidence (RWE) have been actively discussed worldwide in terms of utilization for regulatory decision-making on the benefit-risk assessment of drugs In Japan, the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) have worked to promote the utilization of RWD and RWE throughout a medical product’s
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