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- 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
- 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
- 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 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
- 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
- eCTD v4. 0: A Look at 2025 and Beyond
The full acceptance of the format by US FDA and Japan PMDA makes it a viable option, and most vendors support the format already It is definitely time for sponsor organizations to prepare for the US and Japan mandates and get the regulatory and IT infrastructure support in place
- Global Electronic Labeling Initiatives: Updates from Japan, Canada . . .
Electronic labeling is the focus of many ongoing initiatives across regions E-labeling can deliver the latest labeling information immediately and in an efficient and customer-friendly way for patient safety
- 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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