Japan Advances Regulatory and Reimbursement Frameworks for SaMD Products After a slow start, Japan is now taking decisive action to modernize its regulatory and reimbursement systems for Software as a Medical Device (SaMD), aiming to match the rapid pace of global healthcare... Read More
As noted in our newsletter over the last year, Japan’s MHLW has tried to partially correct the Japan drug lag problem by allowing for higher prices for innovative drugs. Under the 2024 drug pricing reform, the MHLW has continued to support the Price... Read More
Over the last 5 years, relations between the US and China have been deteriorating, while EU-China relations have held relatively steady. However, recently China-EU relationships have begun to deteriorate too. One example of this is an EU investigation to be started soon... Read More
Registering drugs in Japan can be a very tedious process, but the benefits can also be quite large. Japan has a large aging population that heavily relies on new and innovative drugs. Besides a dossier product submission, drug companies need to obtain... Read More
The Japanese government is very aware that many drugs approved in the West are not approved in Japan. The issue of drug lag in Japan is significant as it deprives Japanese citizens of access to the same cutting-edge pharmaceuticals that benefit people elsewhere in... Read More
Japan’s medical device market is the third largest medical device market in the world, after the US and China. While it is a highly competitive market, unique products with good value propositions can be very successful there. While in the past Japan... Read More
Hoping to revamp its pharmaceutical landscape, Japan is trying to balance the scales of drug pricing, innovation, and access to cutting-edge medications. These efforts, led by the Ministry of Health, Labour and Welfare (MHLW) and the Drug Pricing Organization (DPO), reflect a... Read More
Japan reduces drug prices every two years or more recently yearly. As announced on March 5 in the MHLW‘s gazette, starting April 1, drug prices will be reduced by about 4.7% for about 13,000 products including 7,000 oral drugs, 3,600 injectables, 2,000... Read More
In an effort to improve the Japan drug lag problem, the Japanese government plans to initiate several programs to simplify and optimize its drug clinical trial program. First, there are too many systems for clinical trials in Japan including the PMD Act,... Read More
IVDs, drugs and medical devices have different reimbursement pathways in Japan. Normally, for all these paths, a reimbursement application is submitted after product approval. Reimbursement is then normally determined within 3-6 months. However, the MHLW is allowing some companies to have a pre-reimbursement meeting. For... Read More