Japan Pushes for Speedier Domestic Approval of Medical Technology

The Pharmaceutical & Food Safety Bureau of Japan’s Ministry of Health, Labor & Welfare (MHLW), which authorizes new medical devices, held a meeting called the “Study Panel for Quick Introduction of Highly Demanded Medical Technology” on Oct. 26 along with many leading physicians to investigate how to bring highly demanded new technology—both unapproved devices as well as those being used off label—into the Japanese marketplace more quickly.

Japan is well known for its onerous device approval process. Often, devices may take longer to be approved in Japan than they do to be introduced in the United States or Europe. Japanese physicians have been strongly advocating that the latest medical technology be made available to their patients in a timely fashion, so they can reap the benefits of these devices that are afforded to their US and European counterparts. Physicians in Japan who have experienced US or European medical practices have voiced particularly loud concerns about their inability to use the latest technologies.

The debate was, in part, sparked by growing attention to lagging approvals for drugs, especially cancer treatments, that could have lifesaving consequences for Japanese patients. The problem is no longer just a frustration—many view it as an overreaching social problem. As the topic gains more public attention, the similar plight of the medical device community is being examined as well.

In response to this attention and the criticism coming from physicians, the MHLW has been stepping up its attempts to foster discussion with the medical community regarding  new medical devices that are in high demand. New technology discussed at the Study Panel’s meeting in October included unapproved devices or off-label use devices that have been widely used in other leading countries and proven to have had significant impact on the diagnosis and treatment of life-threatening diseases.

How Japan Is Fostering These Changes

In an attempt to examine the unapproved new technology and to explore whether better alternatives exist, the MHLW will organize working groups consisting of specialists from various medical fields and select the most highly demanded technologies that should be given priority.

In one measure to quickly approve the particular devices prioritized by the meeting, the MHLW will attempt to speed the approval process by having working group and the Pharmaceuticals & Medical Devices Agency (PMDA)—Japan’s version of the FDA—work together to evaluate submissions. Under the plan, vendors who wish to introduce their prioritized devices quickly to the market can provide information about their product and its development process. In addition, these companies must provide supporting clinical data and usage data from other countries using the product.

Upon nomination for a “priority” introduction (ie, speedy approval), the PMDA will review the materials first and then report on its findings to the working group, which additionally will serve as an intermediary, providing applicants advice on the submission and review process, as needed.
    

Related Initiatives  Aid Approvals

Besides the aforementioned study panel, a separate meeting of the “Study Panel for Evaluation of Medical Effects by Introducing Unapproved Medical Devices” was organized by the Health Policy Bureau of MHLW. This group has been charged with helping to evaluate and predict the potential medical effects associated with the use of unapproved medical devices or those being used off label for unapproved use not only from the point of regulatory approval but also from the point of reimbursement. Consisting of leaders from both the public and private sectors, and working in conjunction with the Medical Technology Promotion Council of the Medical Engineering Industrial Strategy Consortium, the panel widely has been supported by the MHLW; Ministry of Economy, Trade and Industry; and the Ministry of Education, Culture, Sports, Science and Technology.

The panel will be looking at devices that are widely used in the world market but not approved in Japan or approved only for the limited indication for use and are being used for off-label indications. The unapproved devices will be studied, as will the scientific rationale for the device’s efficacy; in addition, the manner in which the device is being used off label will be examined. The demographics and size of the potential patient population as well as the properties of the device are some of the factors that the group will examine as it evaluates the merits of approving the device for additional indications for use.

The panel invited applicants for this evaluation to begin submitting materials as of Dec. 1, 2006. The fate of these devices will be decided by this April.

Clinical Trial Update

The PMDA also has been looking at additional ways to speed up the approval process for devices. The agency recently released an interim report by its Clinical Trial Examination Committee, which analyzed the clinical trial process for medical devices and drugs. Some areas of interest include the manner in which clinical trial data are evaluated (and the impact of clinical data from foreign countries); promotion of preliminary consultation with the PMDA before a clinical trial is instituted; and promotion of an international joint clinical trial.

Regarding the improvement of Japan’s domestic environment for clinical trials, the report examined the current enforcement of the clinical trial infrastructure among domestic medical institutions as well as enforcement of good clinical practice compliance check. Specifically, the committee analyzed the current problems and proposed future solutions.

In terms of the acceptance of foreign clinical data, the committee recommends that the PDMA disseminate information directly to foreign manufacturers on how the PDMA has reviewed this information (including success stories for products that have gained approval) and how it plans to do so in the future. The committee also recommended that manufacturers demonstrate awareness of the new international guidelines for device evaluation, under development by the Global Harmonization Task Force.

In terms of promotion of international joint clinical trials, the committee recommends exploration of the possibility of the MHLW and US FDA working together in some type of capacity.

The limited scope of preliminary consultation between device companies and the PMDA has been a source for industry concern. To cope with broad range of requests, the PMDA decided to break the consultation service into specific services beginning in fiscal 2007. Preliminary discussion between device companies and the PMDA will consist of consultation for development, an application submission consultation, a consultation for clinical trial development, a review prior to application submission and any additional consultation, as needed. By introducing a framework for pre-approval consultation, the PMDA is trying to cope with the market’s concerns. This is obviously good news for the industry, as the applicant can make sure in advance if its regulatory strategy is correct. However, the question becomes whether the consultation services will be performed effectively in a timely manner given the current the limited resources at the PMDA. The reinforcement of the PMDA’s infrastructure and manpower are critical to the program’s success.

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].