The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently announced that it would aim for increased speed to market for innovative medical devices and pharmaceuticals. The PMDA plans to complete 70% of device and pharmaceutical reviews within 12 months in 2015– compared to a target of 60% in 2014. However, the PMDA will prioritize applications from domestic medical device and pharmaceutical companies. By 2019, the PMDA hopes to complete more than 80% of device and drug reviews within one year.
Japan is also working to reduce its “medical device lag” — after approval in the U.S. or European Union, new and innovative medical devices face an average 4 year delay before they reach the Japanese market. To reduce this device lag, the PMDA will potentially offer better reimbursement for companies that submit approval applications in Japan soon after submission in the U.S. or European Union.
Also, the PMDA has released plans to roll out an internet based patient drug adverse reaction reporting system by Japanese fiscal year 2018. A pilot system has been in place since March 2012. Information submitted will be used to supplement reports from the current drug adverse reaction reporting system for medical institutions.