On April 1, 2009, the Japanese government decided to bring the “me-too” application category back to its medical device registration system. “Me-too” devices are those that are demonstrated to be equivalent to devices that already have market approval in Japan. The enforcement of the new Pharmaceutical Affairs Law (PAL) in 2005 had abolished the “me-too” category, but the PMDA has decided to reinstate it to facilitate the review process. There are now three tracks for medical device registration applications: one for completely new products, one for improved products, and one for “me-too” products.
Along with the addition of the “me-too” category, the PMDA’s medical device review fees also increased on April 1. This fee increase was planned to finance the hiring of more reviewers so that the PMDA can streamline its registration application process. (Please see Volume 9, Issue 3 of the PBM newsletter for more information on the change in fees.)
Device review time should be reduced in the future. In addition to hiring more reviewers in accordance with its action program, the PMDA will also allocate specialized reviewers for each application category by 2011.
Furthermore, the PMDA is streamlining the application document requirements for the “me-too” and improved product categories. The target review time for the “me-too” category is four months. The target review time for the improved products category is ten months for products that require clinical trial data and six months for those that do not.
With respect to drugs, the PMDA now delineates what kind of information will be shared with applicants at each phase of their new drug application (NDA) review. This practice just started in April 2009. For instance, after receipt of the application documents for the NDA, the PMDA will inform the applicant of the schedule for the first meeting with the PMDA, the expected delivery date of the first inquiry from the PMDA, and the current document review order.