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, Japanese pharmaceutical industry leaders 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 distribution. ... Read More
Contact us today to learn more about how Pacific Bridge Medical can help you file a device MF in Japan. Background information The original Japanese Device MF system was established in December 2000. This system is called the “Old MF system”. At that... 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
If your company wants to enter the Japanese market and is interested in our DMAH service, contact us today for a free consultation. Currently the third largest medical device market in the world, Japan presents many opportunities for foreign medical device companies. However, only... 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
Contact us today for a free consultation with our Japan DMF expert. Currently the third-largest pharmaceutical market in the world, Japan presents many opportunities for foreign drug companies. Major factors such as a rising incidence of chronic diseases and a rapidly aging population... Read More