Japanese Pharmaceutical Affairs Law (PAL) 

On March 17, 2000, Japan's Ministry of Health and Welfare (MHW) issued a seirei, or cabinet order, to amend the Pharmaceutical Affairs Law to revise procedures for processing product approval applications for medical devices. This order became effective on April 1, 2000. Under the new system, the previous application category for medical device approvals was restructured into three categories; 1) "new devices" 2)"improved or modified devices," and 3) "me-too devices." Under the new policy only "me-too devices" are now subject to equivalency review by the Japan Association for the Advancement of Medical Equipment (JAAME).

The purpose of this measure is to remedy the problem of redundant application reviews of product approval applications by two separate agencies, the Japan Association for the Advancement of Medical Equipment (JAAME) and the Pharmaceutical and Medical Device Examination Center (PMDEC). The elimination of redundancies in the review process is intended to expedite the medical device approval process.

Background:

In July 1995, in an effort to accelerate the process for reviewing medical device product approval applications, MHW granted the Japan Association for the Advancement of Medical Equipment (JAAME) the authority to perform a portion of the review procedure. The JAAME's expanded role applied to making the determination of equivalency between a "me-too" medical device and other classes of devices. A device determined to be equivalent to already approved products, benefited from less stringent review. New devices, those identified as having a "new structure," were excluded from this expansion of JAAME responsibility.

In July 1997, in order to further expedite the review process, MHW established the Pharmaceutical and Medical Device Examination Center (PMDEC) to perform evaluations, other than the equivalence investigation. PMDEC evaluations were to be conducted, whenever necessary, after the investigation by JAAME. However, in practice, the PMDEC has often re-evaluated the applications recommended as me-too devices by JAAME, resulting in delayed product approvals. MHW designated the JAAME with the authority to evaluate and make recommendations on the approval of "me too" devices; therefore, PMDEC added no value by re-evaluating such applications.

Given the rapid innovation that has become the norm in the medical device industry, and the corresponding shortening of product life-cycles, even modest delays in bringing new products to market can result in large potential revenue losses for manufacturers. As a result, device manufacturers marketing their products in Japan have watched with increasing concern as redundant application reviews have delayed product approvals.

In trade discussions conducted under the auspices of the Market- Oriented, Sector-Selective (MOSS) Medical Device and Pharmaceutical Agreement, the U.S. Government (USG) has asked Japanese Government authorities to take measures to prevent redundant regulatory review by PMDEC and JAAME in the approval of me-too medical devices. The USG has specifically sought to ensure that decisions made by review personnel are treated as binding commitments by the reviewing institution and are binding on other reviewers later in the review process.

In the Second Joint Status Report (JSR) of the U.S.-Japan Enhanced Initiative on Deregulation and Competition Policy, released in May 1999, MHW agreed to ensure that the consistency and speed of the approval process for medical devices will be improved, and to take necessary measures to meet this goal by April 1, 2000. At bilateral trade discussions held in February 2000, MHW officials reported that device applications will be organized into three categories in April 2000. The categories will be designated as "new devices", "improved or modified devices" and "me-too devices." Under the new system for classification of applications, MHW will no longer requires equivalency review for "new devices" and "improved or modified devices" at JAAME. These applications will be exempt from JAAME scrutiny and be reviewed only at PMDEC. JAAME will only conduct equivalency review of "me-too devices."

MHW has issued a notification describing items necessary to determine the "equivalence" of a given medical device. It is the applicant's responsibility to make a judgement under which classification category their products should be submitted for review.