China’s law (Implementing Regulations of the Drug Administrative Law) is currently being updated and out for public comments until June 9. The draft regulation includes over 181 articles or over 100 more articles than the current law. Some possible changes among other... 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
Opportunities in China for novel drugs will continue to grow despite recent NRDL price cuts. For example, Novartis sales in China are close to $3.1 billion a year, and last year sales grew by double digits. 2025 sales are expected to top $4.2 billion... 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
In the past, hospitals made money in China by marketing up drugs, devices, procedures, and doing many diagnostic tests. Those days are over. As mentioned in our previous newsletters, China’s Volume Based Procurement (VBP) has cut the reimbursements for many high priced... 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 21, 2022, China’s Ministry of Science and Technology (MOST) released the draft version of the Implementing Rules for Human Genetic Resources Management to seek public opinion by late April. The release of this document signals the Chinese authorities’ intention to help facilitate clinical... Read More
On March 31, the Japanese MHLW issued a notification allowing CDxs 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 that have identical indications. ... Read More