In a push to speed drug approval times amid the coronavirus pandemic, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is finalizing plans to permit drug companies to supplement or replace their own clinical trials with data from patients who have taken the... Read More
China, Korea, Taiwan, and Japan are rapidly becoming world leaders in cell and gene therapy research and innovation, fueled by significant public and private investment and streamlined regulations that are spurring breakthroughs in the field. All three countries have long been leaders... Read More
Globally, there has been a trend toward using more real-world data in the development of drugs and devices. Japan’s MHLW is also taking note and has drafted 2 new guidelines – 1. A basic policy on using registry data in registration submissions... Read More
Seeking to ensure clinical trials are accurate, credible, and safe while protecting the health of its personnel during the COVID-19 pandemic, Japanese regulators will continue to conduct Good Clinical Practice (GCP) inspections remotely through April 1, 2021. The announcement by Japan’s Pharmaceutical... Read More
Pushing to speed its historic lag in drug approval times compared with the United States and the European Union, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) is bolstering the ranks of its product review staff and making major changes in its approval... Read More
This article was originally published on MedTech Intelligence. With patients and medical providers across Asia and around the world forced by the global pandemic to rely on online platforms more than ever before, the medical device industry is finding itself uniquely vulnerable... Read More
Software as a medical device (SaMD) may be eligible for conditional early review and approval in Japan including diagnostic imaging software and therapeutic apps. Japan’s Pharmaceutical and Medical Devices Law, approved this year, permits manufacturers to get their products rapidly approved even... Read More
Sales of diagnostic mammography equipment in the Asia-Pacific region is expected to rise significantly over the next eight years, according to two recently published studies. The reports by Globalcan and GlobalData vary in their specific findings. But both project compound annual growth... Read More
Radio Frequency Identification (RFID), a fast-developing technology that uses radio waves to collect and transfer data, is increasingly being adopted in healthcare markets across the Asia Pacific region and around the globe. A study by Precedence Research found sales of the technology,... Read More
The long-simmering question of when and how Japan will implement a proposed plan to evaluate and revise drug prices annually, instead of every two years, may finally be resolved next year. That is when a survey being conducted by the Ministry of... Read More