Alarmed by increasing blockages in the supply chain of prescription drugs, the Japanese government is considering requiring manufacturers to alert the government to anticipated shortages of their products. Such a mandate, floated in recent interviews by health officials, would require passing legislation.... Read More
For the first time, regulators in Japan are carrying out surprise inspections at facilities where pharmaceutical and medical device products are manufactured. The inspections, which began in August, are designed to improve Japan’s system for ensuring the products are consistently produced according... Read More
Seeking to topple long-standing obstacles to drug innovation in Japan, pharmaceutical industry leaders in the country have outlined a slate of steps they propose the government take to foster research and development of new products, trim regulations and approval times, and speed... Read More
Background information The original Japanese Device MF system was established in December 2000. This system is called the “Old MF system”. At that time, the applicable raw materials were limited to Polyvinylchloride, Polyethylene, and Polypropylene. The current Device MF system was established... Read More
Three major groups representing pharmaceutical companies doing business in Japan are pushing back publicly at what they call plans by regulators to impose onerous new price controls and regulations that would make it harder for them to bring much-needed drugs to market, ... Read More
With cancer a leading cause of death in Japan, the market for pharmaceuticals to treat tumors is expected to grow by 5% by 2023, and to represent one fifth of the market for pharmaceuticals by 2026. The prediction is part of a... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Currently the third largest medical device market in the world, Japan presents many opportunities for foreign medical device companies. However, only local companies with a Marketing Authorization Holder or Designated Marketing Authorization Holder (MAH/DMAH) license are legally allowed to import and market... Read More
A regulatory pathway that for the past six years has allowed Japan to accelerate the approval of innovative drugs and medical devices deemed to address urgent, unmet needs may be expanded to address the software as a medical device (SaMD) market. In... Read More
The new edition of the Japanese Pharmacopoeia, the official compendium of medicines approved by the government for use in the country, will include 33 new pharmaceuticals, among them antibiotics, excipients, and biologics, as well as many unrefined drugs. Inclusion in the Pharmacopoeia... Read More