Yoshio Mitsumori 05.07.07
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.