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
A recent report by Bain & Company and APACMed (a MedTech trade association located in Singapore) has issued a report on Asian MedTech companies’ growing appetite for ESG initiatives. According to this report, the Asia region has doubled its ESG policies compared... Read More
As noted in our June Pacific Bridge Medical Newsletter, Japan is planning to implement a two-step registration process for SaMD products in early 2024. If a SaMD product shows strong safety and efficacy, it will get initial approval. Later, if the SaMD... Read More
In an effort to reduce the drug lag in Japan, in mid-September, the MHLW said, in general, Phase 1 drug clinical studies are not required before late-stage global studies. This notification will amend the prior notification in 2007 and render invalid a... Read More
While robotic surgical devices have penetrated much of the US and Europe, future growth is expected to be strongest in Asia. It is estimated that Asian surgical robotic sales will hit $10 billion in 5 years. Asia’s quickly aging population and the... Read More
Please click here to access the presentation slides: Japan Pharmaceutical Registration Update 2023 Read More