Yoshio Mitsumori10.06.06
Ever since the new Pharmaceutical Affairs Law (PAL)—which applies not only to pharmaceutical manufacturers but also to medical device manufacturers—was implemented in April 2005, Japan’s regulatory system has drastically changed. Looking back at the past 16 months, this column reviews the impact of this PAL from the viewpoint of a foreign medical device manufacturer.
The basic concept of the new PAL is to shift the weight from the manufacturing service to the field sales, similar to how the United States and Europe operate. Japan’s regulatory system consists of two major systems: one pertaining to the business license granted to a company, called “KYOKA,” and one related to product approvals, called “SHONIN.” Both systems have changed significantly since the introduction of the latest PAL.
The basic concept of the new PAL is to shift the weight from the manufacturing service to the field sales, similar to how the United States and Europe operate. Japan’s regulatory system consists of two major systems: one pertaining to the business license granted to a company, called “KYOKA,” and one related to product approvals, called “SHONIN.” Both systems have changed significantly since the introduction of the latest PAL.