New Report Exemplifies Japan’s Slow Approval Process

As reported in the January/February issue of Medical Product Outsourcing, the Japanese government has been investigating how to introduce advanced medical technology as quickly into the medical arena as US and European markets do. By having strong demands from the medical academy, the device lag—compliments of Japan’s slow authorization process—has been criticized and now has became a diplomatic issue taken up by US and European agencies.
    
In fact, a new report from the US International Trade Commission (ITC) confirmed that manufacturers face longer waiting periods for regulatory approval in Japan compared with other global markets. The ITC, an independent federal agency that researches economic trends related to international trade and investigates unfair trade practices, conducted the study in response to a request from the US House of Representatives Ways and Means Committee, which oversees US trade policy.

According to the report, in 2004, a new medical device spent an average of 1,083 days before gaining approval, compared with only 356 days in the United States. This, in part, might explain why US device companies have significantly decreased their applications for approval of new medical devices—the number of applications has dropped from 132 in 2003 to only eight in 2005, the report showed. This was because many companies had rushed to submit applications before the implementation of the new Pharmaceutical Affairs Law (PAL), and after PAL implementation, they held the new applications to see how PAL reform would affect the new documentation. Even so, eight applications were too few.        

According to the ITC’s report, since US medical device manufacturers are “the world’s leading developers and exporters of high-technology products,” they may be “disproportionately affected” by the regulatory delays, compared to companies in other countries.  

For example, Boston Scientific’s Taxus drug-eluting stent has been on the US market since 2004 and only received approval in Japan at the end of March. Prior to this clearance, only Johnson & Johnson’s Cypher drug-coated stent had been available in Japan.

With more than 127 million residents, Japan is the third largest consumer of medical devices globally, accounting for an estimated 10% of worldwide spending. Add to that the knowledge that the Japanese population contains more individuals age 65 and older than does the United States and Europe (which are the first and second largest consumers, respectively) and that this population is expected to consume a large portion of medical products in the next couple of decades, and it’s obvious that the slow approval process needs to be addressed.

Yoshio Mitsumori is the president and CEO for Tokyo-based ADMIS, a consultant specializing in the medical device industry. He has more than 25 years of experience in the medical industry, including positions with the Itochu Corp., U.S. Surgical, National Medical Enterprises and Century Medical. A member of RAPS, he has spoken at many industry events and worked extensively in international trade of medical products and technologies. He can be reached at [email protected].