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
On March 31, the Japanese MHLW issued a notification allowing CDxs in Japan to be used for more than one drug, in addition to the initial treatments they were originally approved for. In the past, different CDxs were available for unique drugs... Read More
Reimbursement for medical devices in Japan is determined by functional pricing and foreign reference pricing. Every 2 years the Japanese government issues new medical device pricing in April. This year, the reimbursement for their foreign reference pricing formula will be reduced as... Read More
Every 2 years, Japan’s drug prices are revised and generally downward. The Japanese government surveyed 75 drug companies and 200 drugs recently. Of the 200 drugs, 44 will have price reductions of double digits next month. For example, Shionogi’s Crestor will be cut... Read More
On March 1, the Japanese cabinet issued a draft bill which creates an emergency approval system for devices and drugs. The draft will make it easier for these medical products to receive approvals based on presumed efficacy if there is an emergency. For... Read More
Japan is the fastest aging country in the world. With about 125 million people now, their population is expected to decline to 90 million in 25 years. In an effort to increase their population, starting this month, Japan will begin to reimburse... Read More
Japan is way behind the US and EU for approving medical devices with AI. In September 2020, Japan introduced the IDATEN system (improvement design with approval for timely evaluation and notice) which was designed to quickly allow partial modifications of approvals for... Read More