2018年4月1日 · PMDA has worked to promote utilization of RWD such as electronic medical records (EMRs) and data of patient registries for drug safety assessment. In order to promote …

2017年12月15日 · 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’s Washington DC Office will promote further international regulatory harmonization and disseminate medical product-related information on and from Japan. PMDA intends to …

FDA and PMDA proved to be flexible regarding drug inspections and willing to carry out the work in a remote manner. Public transparency of scientific information was also enhanced during …

PMDA has drastically shortened its review times, which has resulted in a substantial decrease of the so-called “drug lag.” Recently, PMDA established the Asian Training Centre (ATC) for …

2022年9月1日 · As the above table shows, there is great room for improvement in implementing Sakigake. Due to resource issues, such as the scarcity of PMDA review officers, the number …

2021年9月26日 · Outcomes of Regulatory Science. PMDA has improved its global standing among regulatory authorities by building up its scientific capabilities to accelerate new drug …

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 …

The PMDA will continue to make efforts to promote the appropriate utilization of RWD/RWE in the regulatory setting. We look forward to more discussions, international collaborations, and …

A session at DIA Europe 2021 explored the current implementation of the E17 guideline internationally, both from a regulatory authority and industry point of view discussing …