New Report Exemplifies Japan’s Slow Approval Process
Yoshio Mitsumori
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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.
MHLW Responds to Issue
To cope with the strong demand, the Ministry of Health, Labor & Welfare (MHLW) has organized its Study Panel for Quick Introduction of Highly Demanded Medical Technology. To date, the panel has received 114 requests from 38 medical academies. Of these requests, the specialized working sub-committee selected 94 candidates (59 of which are medical technologies) recommended by 33 medical academies for approval consideration due to the seriousness of the associated diseases and clinical usefulness of the device. The panel finally picked 13 devices as priority devices that should be quickly evaluated and introduced to the market.
The devices selected as a priority for quick introduction include the following:
• Thoracic aortic stent graft
• Carotid artery stent
• Artificial blood vessel
• Implantable artificial heart
• Intravascular embolic material
• Thoracoplasty system
• Capsule endoscope
• In-vitro diagnostics
• Radiotherapy system
• Implantable Holter ECG monitor
• Bone cement
• Radiotherapy supplement system
• Pacemaker lead dislodgment system
With this decision, the MHLW has asked the manufacturers of these products to release detailed technical information about the device as well as clinical data, usage information in other countries and other relevant information.
The PMDA Adds to Efforts
Along with the MHLW’s activities, some developments have been occurring at the Pharmaceuticals and Medical Devices Agency (PMDA).
To avoid misunderstanding and confusion about the regulatory process, the PMDA’s face-to-face consultation system has been considered a good measure to improve communication between reviewers and applicants. However, face-to-face consultations with the PMDA only have been available for preliminary clinical trial consultations or for general consultations that can help applicants identify the device’s probable classification.
Realizing that applicants tend to have a wider range of queries and needs during a consultation, the PMDA has decided to segment the consultation system into more specific categories. Now, medical device consultations are segmented as follows:
• Pre-submission
• Safety validation
• Quality assurance validation
• Functional validation
• Clinical data evaluation
• Bridge study based on existing data
• Full scope clinical trial
• Submission procedure
• Additional consultation
• Documentation for tissue products
In addition, the PMDA has created consultation segments to discuss good manufacturing practices and management of quality systems.
Of course, user fees vary among all the different types of consultations.
Complementing the ramped up efforts to strengthen the consultation system, the agency has decided to increase the number of reviewers it uses in an effort to speed up the evaluation and consultation process. The PMDA will hire 240 new reviewers over the next three years and hopes to bring the approval process in line with the United States and Europe by 2012.
Since Japan has been criticized for taking too long to evaluate products—compared with the United States and Europe—mainly due to the shortage of manpower, the PMDA’s increased personnel for reviews appears to be addressing this problem. Unfortunately for device manufacturers, though, this action only applies to pharmaceutical products for now.
Philip Agress, vice president for global strategy and analysis with AdvaMed, a Washington-based trade group for US medical device manufacturers, said in the St. Paul, MN Pioneer Press that medical devices being evaluated in Japan often are being reviewed by reviewers with expertise in pharmaceutical products, which can result in a disconnect between the reviewers and the devices.
In addition, he noted that reviewers who are used to examining drug studies look for “double-blind” clinical trials—in which neither doctors nor patients know which study participants are taking drugs or placebos—for devices, and this isn’t possible for products such as a pacemaker.
To pay for the additional reviewers, the PMDA already has increased the user fee for the evaluation of pharmaceutical products. For example, the application user fee for a new drug has jumped from 9.8 million Yen (about US $85,000) to 23.8 million Yen (about US $207,000).
Although the medical device user fee hasn’t been changed yet, it should be only a matter of time before this fee increases as well. Otherwise, you won’t see additional personnel added for reviews of medical devices and, thus, no concrete action to prevent the slow evaluation of devices.
