Beginning in September, Japan will enforce recently codified amendments to its Pharmaceutical and Medical Device Act, affecting quality management, device registration, the regulation of medical software and third-party certifications. The new requirements, designed to guard against health problems associated with poorly regulated... Read More
Systematic evaluations of the effects of health technologies in Japan, China, and South Korea conducted over the past three years are showing success in determining the clinical benefits and cost-effectiveness of widely used drugs, adjusting pricing of drugs and medical devices and... Read More
This article was originally published on MedTech Intelligence. Driven by an aging population with growing needs for new medical technologies—and more means to pay for them—governments and hospitals in China, Japan, Singapore, Thailand and Korea are joining forces to purchase an increasing... Read More
One year after Japan tightened its drug pricing system in a bid to make cutting-edge treatments more affordable, the restrictions threaten to slow drug sales to the country, a pharmaceutical industry leader warned last month. Under the new policy, announced in 2018,... Read More
This article was originally published on Medtech Intelligence. Precision medicine, an emerging toolkit of ways to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective, has grown unevenly outside... Read More
Six months after Collategene became the first gene therapeutic drug cleared for use in Japan, the country’s health insurance system announced in September 2019 it would be placed on the list of pharmaceuticals approved for coverage. The drug, which introduces genes that... Read More
Japan’s health ministry will conduct a survey to evaluate drug pricing in advance of the regular biennial pharmaceutical price revision slated for April 2020. The decision to conduct the survey was solidified in June, when the Central Social Insurance Medical Council, commonly referred... Read More
A cutting edge cancer therapy from Swiss pharmaceutical maker Novartis that genetically modifies a patient’s own immune cells to treat acute lymphoblastic leukemia is now covered by Japan’s national health insurance system. The drug, Kymriah, is more expensive than any other cancer... Read More
The use of genetic or molecular profiling, known as precision medicine, is growing in popularity and usefulness throughout Asia, as doctors become more adept at selecting treatments that are most likely to help patients based on a genetic understanding of their disease.... Read More
Seeking new ways to provide healthcare to its aging population while mitigating the impact of soaring healthcare expenses, the Japanese government is adopting a raft of policies to encourage medical innovation. It is promoting the use of artificial intelligence, big data and... Read More