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
The majority of medical and in-vitro devices sold in Japan will be required to post package insert information to a website maintained by the country’s Pharmaceuticals and Medical Devices Agency, in accordance with a new regulation going into effect on August 1.... Read More
New guidelines on software applications released by Japanese regulators seek to help manufacturers and consumers understand which programs, features, and products constitute a medical device, and how such products—increasingly prevalent in the Japanese market—will be regulated. Released in March by the Ministry... Read More
With the ubiquity of smartphones driving a revolution in the use of software to perform medical functions, Japan’s authorities have responded by setting up several new regulatory units to review the growing class of software-driven devices. The offices established in April include... Read More