On April 1, 2023, new drug prices will take effect in Japan. While price reductions have historically been every two years, recently, new price lists have been announced each year or during so-called “off years”. If the difference between the National Health... Read More
At a March 13 PMDA meeting, the priority review time for SaMD products was set at 6 months. SaMD products with strong effectiveness will enjoy SaMD priority review if the SaMD product is submitted first in Japan or simultaneously with other global... Read More
Up until 10 years ago, very few phase 1 studies were done in Asia. With limited drug R&D capabilities, new drugs mostly came from the US and EU. According to a recent report by Novotech, the last ten years have seen a... Read More
Since 1999, Japan’s MHLW has had strict restrictions on the disclosure of Japanese drug clinical trial information to non-medical audiences. Information like the name of the investigational drug or the specific clinical trial code was not available. On January 24 this all changed. Now,... Read More
On January 13, various members of the Japanese Health ministry met and discussed the need to improve orphan drug designation and approval. Increased funding for orphan drug development was debated. Orphan drug designation (ODD) can be achieved in the West with Phase... Read More
About 2 years ago, China implemented its patent linkage system. Geared towards helping foreign companies to bring new drugs to China and helping local Chinese generic companies promote their products, to date, about 30 patent linkage cases have been reviewed by the... Read More
While still behind the US and EU CDx markets to date, over the next 5 years, more and more CDx’s will be registered and used for precision medicine in Asia. Drug companies doing clinical trials and launching new drugs in Asia will... Read More
As medical care becomes more personalized, more drug companies are looking to utilize CDx’s to determine which patients will be responsive to their drugs. Unlike the US and EU, CDx registration is relatively new in Japan. In Japan, the first PMDA notification... Read More
The Japanese government is considering a new program to shorten the approval review for software as a medical device (SaMD) and AI products. Currently, approval of these types of products can take several years in Japan. With the new regulations, approvals could... Read More