Why Japan? The Positive Impact of Including Japan in Drug Development
PMDA highly recommends that developers design study and development plans from an early stage that include non-US regions (such as Japan) for efficient global development. Initiating early …
Utilizing Real World Data: A PMDA Perspective - DIA Global Forum
Apr 1, 2018 · 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 …
The Philosophy and Pathway for Implementation of Regulatory Science …
Sep 26, 2021 · Prospects for PMDA’s Implementation of Regulatory Science in Pharmaceutical Regulation I believe policy initiatives in medicine must be patient-centric, while making full use of …
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 …
PMDA Puts Regulatory Approval on a Fast Track - DIA Global Forum
Dec 15, 2017 · 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 …
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 …
Sakigake System: From Pilot to Permanent Summary and Impact of ...
Sep 1, 2022 · 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.
Defining Gene Therapy Medicinal Products in the EU
In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) groups GTMPs under the more inclusive label of “regenerative medicine product,” which includes products “containing genes to be …
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 …
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, …