While Japan is a huge drug market with decent reimbursements, in many ways it is not progressing as quickly as many developed foreign drug markets. In an effort to jump-start more drug activity in Japan, in early July, the Japanese MHLW will... Read More
Korea’s Ministry of Food and Drug Safety (MFDS) has announced that all RWE can be used as clinical data to expedite the registration of medical devices in Korea that utilize digital technology like AI, Big Data, and some software applications. The MFDS... Read More
While the West and Japan are prioritizing personalized medicine and the use of Companion Diagnostics (CDx) to determine which patients will benefit from specific drugs, development in China has been slow. CDx products in China are classified and regulated by existing medical... Read More
Drug prices in Korea, like other markets around the world, have seen drug price erosion. Korea’s MOHW, earlier this year, established a private-public working group to discuss increasing reimbursement for innovative drugs. The goal of the Korean group is to foster new... Read More
The China cancer drug market is experiencing exponential growth. According to a recent Research and Markets report there are about 5 million cancer patients in China now and by 2027 the market size will be over $35 billion. Cancer is rampant in... Read More
Normally, every two years in April the Japanese government revises drug prices. Recently, such revisions have occurred annually or in so-called “off years”. Drug price revisions went into effect on April 1st, 2023. Drugs in Japan with price variances between their market... Read More
On April 4, China’s NMPA promulgated 2023 new medical device registration guidelines. These guidelines affect China medical device registration, type testing, clinical trials, etc. The guidelines for Class 3 medical devices include 36 new guidelines and 27 revisions. Examples of Class 3... Read More
Japan has been slow to approve SaMDs but hopes to finalize its registration system for these products in 2024. On May 29, after a working group session that included the PMDA and Chuikyo (Japan’s reimbursement agency) to discuss SaMD registration, a guidance... Read More
Singapore’s HSA’s last update on GN-14 was made in 2018. Now, a new draft was announced on May 2. This document outlines and revises the risk classification of IVD medical devices in Singapore. For example, IVD medical devices that recognize the existence... Read More
While LDTs have been used in the US for over 30 years, they have not been utilized in China. In 2021, China issued its first LDT regulations, but they were vague and led to uncertainty. Recently, China has issued some new regulations... Read More