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 RWD utilization by pharmaceutical companies, the ministerial ordinance (Good Post-Marketing Study Practice, or GPSP) was amended in October 2017 and implemented on April 1, 2018.

PMDA’s Washington DC Office will promote further international regulatory harmonization and disseminate medical product-related information on and from Japan. PMDA intends to counteract “urban legends” about Japan and promote the development of innovative medical products in Japan through this office.

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 remained in limbo considerably longer without the sakigake fast-track review system. With the recent regulatory initiatives, PMDA has met the major targets of its Mid-Term Plan ...

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 the pandemic; for instance, FDA and PMDA promptly disclosed safety and adverse event reports of vaccines to build and sustain public confidence in health ...

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 of Breakthrough Therapy designations under the US FDA and of PRIME designations under the EU EMA will be more than the number of Sakigake designations in Japan for the foreseeable future.

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 review and safety measures, demonstrated by the world’s fastest review speed for new drugs with new active ingredients for three consecutive years from 2014 to 2016.

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 further accumulation of regulatory experiences aimed at facilitating appropriate RWE-based benefit-risk assessments of drugs, medical devices, and regenerative ...

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 Pharmaceuticals and Medical Devices Regulatory Affairs and the Center for Regulatory Science.

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 experiences from the Pharmaceuticals and Medical Devices Agency (PMDA) Japan, the European Medicines Agency (EMA), and industry on the use of the guideline in practice, as well as how to address …

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.