In a meeting on May 8, Mr. Katsufumi Jo of Japan’s Upper House Health Committee within the Ministry of Health, Labour and Welfare (MHLW) described the scope of Japan’s newly widened conditional approval scheme for drugs. He said that the expanded scheme is intended to... Read More
The Korean Ministry of Food and Drug Safety (MFDS) has introduced a new initiative focused on three aspects: organoid alternatives to animal testing, legal framework for CDMOs, and the acceleration of GMP inspections. First, the Bio Future Development Council will establish regulations... Read More
As relationships with China falter and China wants to make everything in-country, more Western device companies are looking to India not only for sales, but for sourcing, R&D, local manufacturing, etc. The Indian government has promoted medical device manufacturing via its National... Read More
Taiwan’s National Health Insurance Administration (NHIA), a division of the Taiwanese MHLW, has announced a new program to fund new cancer drugs. The goal is to expedite the incorporation of new cancer drugs into the national healthcare scheme. The program is called... Read More
Introduction In the fast-paced medical device industry, product quality is essential to guaranteeing patient safety and public confidence. Across the world, regulatory bodies have established stringent quality systems to manage and enforce standards throughout the life cycle of a device. In Asia,... Read More
Asia’s growing healthcare needs and aging populations offer a significant opportunity for medical device manufacturers from around the world. However, market access to the biggest economies in Asia – China, Korea, and Japan – usually entails navigating complicated and rapidly changing reimbursement... Read More
As global drug companies look to expand into Asia, having insight into the drug market access environment in China, Korea, and Japan is more important than ever. Although the drug registration procedure is getting less complicated in these markets, market access in... Read More
In the international pharmaceuticals industry, Good Manufacturing Practice (GMP) compliance is a fundamental foundation for the safety, quality, and efficacy of drugs. With expanding supply chains and more complex global partnerships, knowledge of the quality compliance environments of leading Asian pharmaceutical markets... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
As reported over the last year or so, Japan is trying to fix its drug loss problem, where many drugs approved in the US and EU are still not approved in Japan. Based on past drug approvals in the West, from 2016 to... Read More