While RWE is fairly prevalent for US and EU drug companies in their home markets, this has not been the case in Japan. However, according to a recent McKinsey article, this will change in the near future and become a more common... Read More
On June 1, 2022, Japan’s PMDA‘s Medical Device Quality Control and Safety Measures Department issued an administrative communication called the “Documents to be submitted when applying for a QMS conformity inspection.” Administrative documents with the same QMS content have been published for some time, but this latest... Read More
In the past, Japan has adjusted drug prices every two years. However, in 2022, the Central Social Insurance Medical Council known as Chuikyo had its first off-year re-pricing. In 2023, Chuikyo will have its second off-year repricing which will take effect in... Read More
Many Western medical companies are coming out with unique software with healthcare applications. Some stand-alone software programs in Japan are classified as program medical devices. Program medical devices generally include a computer program (intangible) or tangible recording media (any magnetic tape, disk, or other... Read More
Due to manufacturing problems with some generic products, the MHLW will now bolster GMP via issuing a new inspection manual. This inspection manual will apply to both generic and new drugs. Representatives from various pharmaceutical associations, the PMDA, and others have now set up... Read More
On May 9, the MHLW issued a notice that they will accept online applications for drugs, medical devices, and regenerative medicine products. Other types of products that can be submitted online include applications for API master files, GCP/GPSP onsite inspections, and partial... Read More
Historically, Japanese drug registration lagged approval in the West by a number of years. However, in the last 7 years or so, regulatory changes in Japan have expedited approval there. These changes include more drug reviewers, a simplified approval process, an updated... Read More
Japan is planning to establish a new system (Kin-kyu-sho-nin) in case of emergencies that will allow new drugs and devices to be urgently approved without going through an efficacy confirmation process. Under this new approval system, manufacturers of new drugs only need to provide existing... Read More
Digital healthcare trends are flourishing in Asia due to its aging population, shortage of healthcare personnel, increasing consumer demand, and technological innovation. According to statistics from Graphical Research, the digital health market in Asia Pacific is expected to grow by 33% from 2020... Read More
Last summer, the Japanese MHLW issued guidelines saying the PMDA and the prefectural authorities should do surprise GMP inspections on factories that have had many previous problems. The surprise GMP inspections were to stop factories from covering up sensitive issues before inspections.... Read More