Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has traditionally been less than receptive to clinical data from other nations, but that aversion is slowly giving way. Ames Gross of Pacific Bridge Medical told BioWorld that a trial conducted in another nation with significant representation of those of Japanese ancestry can go a long way toward obviating the need for a trial conducted in Japan.
In 2023, the med-tech market in Japan was estimated to be $34 billion and the projected growth rate is 3.8% per annum. As is the case with most nations, Japan has a top-heavy demographic that promises a large patient population for cardiology devices and cancer treatments. The median age of the Japanese population is roughly 50 years, significantly higher than the U.S. median of just short of 39 years.
Japan’s GDP in 2023 was $5.8 trillion, which comes to a per-capita GPD of roughly $42,800 for a population of 127 million. Demographically, non-Japanese citizens make up only 1.5% of the population, with immigrants from China and Korea making up roughly 1%.
Gross said that PMDA “is becoming more open to accepting foreign clinical data, so a local study may not be needed” for a medical device. The key is whether device performance varies by ethnicity, but ethnic differences in the natural course of the treated disease are also factors the agency takes into consideration, Gross said.
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