Japan has always been a good orphan drug market with high reimbursement and oftentimes government financial support for development. However, in the past, it was not flexible on designation unless 3 criteria were met – 1. the drug had to treat fewer... Read More
As discussed in our recent news briefs, Japan is initiating a number of regulations to improve its drug market including increasing novel drug reimbursement, expediting its fast-track approval system further (Sakigake), etc. In late December, the Japanese government issued a report that will... Read More
During the last year, we have outlined the steps the PMDA is taking to expedite registration for Software as a Medical Device (SaMD). Besides expanding its SaMD review staff and offering more SaMD consultation sessions, the PMDA presented on January 22nd in... Read More
In late December, the MHLW announced an update to its Sakigake fast-track registration system. In the past, for an innovative drug to be eligible for the Sakigake system, it had to be either filed in Japan at the same time it was... Read More
Japan’s PMDA will open its first overseas office in Bangkok in 2024 or at the latest by March 2025. The new PMDA office will interact with Southeast Asian countries and hopefully improve their knowledge of Japanese requirements. China removes tariffs on 62... Read More
Successful clinical trials in Japan are key to drug registration. There have been several regulations and guidelines for Japanese clinical trials over the years. Japan’s clinical trial regulations are regulated by the MHLW and outlined in the PMD Act as well as... Read More
This article was originally published on MedTech Intelligence. Companion diagnostics (CDx) plays a pivotal role in personalized medicine—one of the fastest-growing areas of medicine. Regulation of CDx is fairly well established in Western countries, but the East is not far behind. Here... Read More
As reported over the last 6 months, Japan’s MHLW is initiating plans to reduce its drug lag and drug loss problems. Accordingly, the MHLW has increased its budget to expedite drug approvals in 2024 and strengthened its price maintenance plan. In addition,... Read More
Meeting Japanese drug GMP requirements is a key factor for drug registration in Japan. In the past, pharmaceutical inspections were done by prefectural governments at generic and other drug factories, and the PMDA did inspections at factories with high-risk drug products, like... Read More
While the US and EU follow ICH’s Q12 guidelines for post-marketing drug approval changes, Japan does not. Post-marketing changes in Japan require applications for partial change approval and minor change notifications for low and high-risk changes. In Japan, these take a lot... Read More