Earlier this month, we learned that Japan may speed up its approval processes for medical products. Up until now, its regulatory approval process has been the slowest among industrialized countries. Would you agree with that assessment, and can you give us some examples of how bad it really is?
Ames Gross, Pacific Bridge Medical: Japan’s regulatory approval process has always required a great deal of time and effort. The Ministry of Health, Labor, and Welfare (MHLW) has promised to improve the review process to reduce the “drug lag” (or “device lag”). Currently, though, the process remains slow. Many regulatory professionals in Japan think it is getting even slower because of a shortage of reviewers at the Pharmaceuticals and Medical Devices Agency (PMDA). For example, the common waiting period to get the PMDA’s initial feedback on a product registration application used to be one month after submission (of course, there was some range on timing depending on the product and individual reviewer). Now, waiting two to three months is much more common. In extreme cases, it has taken five months for the PMDA to provide just an initial response.
Although it is true that the PMDA is hiring new people, personnel turnover can also slow application review. The reviewer who was initially responsible for the application may not have provided enough training or sufficiently explained the situation to his or her counterpart. Then, the reviewer new to the position is unaware of all the details. In some of the worst cases, the new reviewer needs to start from scratch.
In what ways is Japan speeding up its approval process? And why is it amenable to doing so now?
Gross: Accelerating the approval process has been on the Japanese government’s agenda for some time. In 2007, the MHLW unveiled a 5-year strategy to help companies introduce new innovative drugs and devices into the Japanese market. A fuller plan was laid out in an August 2008 draft report, New Medical Device/Medical Technology Industry Vision. Government plans included increasing the number of reviewers, establishing clearer review standards and guidelines, and streamlining clinical trial and product approval processes. The plans outlined in 2007 and in this 2008 report are basically the same, so we do not think the drive for these types of changes has gotten significantly stronger in recent months.
The MHLW also has unveiled other changes. It has announced that it will not require review or re-approval for partial changes to some products, if the partial change does not affect safety or clinical trial results. However, this announcement was somewhat vague and it is still unclear how reviewers will implement it. The MHLW is also supposed to be developing more concrete standards and guidelines to delineate what kinds of partial changes will be affected.
In addition, in late March 2008, the MHLW issued a new rule on government reimbursement for advanced medical technology. Under this new rule, qualified medical institutions can use unapproved new medical products on patients in combination with approved medical products, and the approved medical part will be reimbursed. Patients still will have to pay out-of-pocket for the unapproved medical part. Previously, even approved medical products were not reimbursed if they were used in combination with unapproved medical products. This new rule may help the sales of high-tech medical devices which have not completed the lengthy product approval process.
While some progress has been made, plenty of obstacles remain for nondomestic companies wanting to enter this market. Could you indicate the most important ones?
Gross: Japan’s Pharmaceutical Affairs Law (PAL) is often ambiguous in application, and it can be difficult to predict how reviewers will interpret it in a given situation. In some cases, interpretations of the PAL that were considered standard can switch in the course of a year or two. Also, the various MHLW and PMDA notices and ordinances come quickly, so keeping up with them is a constant effort. Furthermore, the MHLW can give guidance to the industry orally, and if a foreign company’s regulatory professionals fail to attend certain events, they can miss some of this guidance.
Ames Gross, MBA, is recognized nationally and internationally as a leader in the Asian medical markets. Since founding Pacific Bridge Medical (PBM) in 1988, he has helped more than 200 medical companies with business development and regulatory issues in Asia. In 2008, MD&DI magazine named Gross one of the top 100 executives in the medical business. Gross is a frequent contributor of articles on Asian medical issues for Clinica (London) and MD&DI (Los Angeles), and other medically oriented journals. He has been a featured speaker on issues involving the Asian medical markets at the Medical Design and Manufacturing events, Medtrade Home Health Care Exhibition, Regulatory Affairs Professional Society meetings, and similarly oriented meetings and conferences. Prior to establishing PBM, Gross gained broad experience, knowledge, and contacts in Asia while working at three major Wall Street firms. He has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University. For more information about PBM, view its listing in the online Consultants Directory or go to the firm’s Web site at www.pacificbridgemedical.com.