How To Run Successful Clinical Trials In Japan

There is no longer any excuse not to include Japan as an integral part of any global clinical-development program for either pharmaceuticals or medical devices. With a more receptive climate for both starting and running trials, an improved infrastructure for clinical research, and significant advances in accelerating drug approvals, Japan is now firmly on the global development map.

There have always been strong reasons to secure a foothold in Japan. It is the world’s third-largest single pharmaceutical market after the US and China – or second-largest for prescription drugs – with a rapidly aging population (26.6% over 65 years old in 2016) increasing the demand for healthcare and medicines.

Other compelling reasons to always involve Japan in global drug development include: a mature local market; a renewing economy; the regulatory flexibility around Japanese data in global clinical-trial packages; an extensive, nationally-funded healthcare infrastructure with universal health insurance; a large and adherent patient population; and a strong emphasis on quality and precision in clinical research.

Japan’s attractiveness for the inward investment proposition for the pharmaceutical sector has further increased in recent years as the Japanese regulatory authorities have made concerted efforts to align drug approval timelines with the US and Europe. The situation in Japan today is a far cry from before, when Japanese patients had access to new medicines five to ten years after their counterparts in the US or Europe.