Japan has accepted the changes necessary to reach agreement. The regulatory authority The Japanese regulatory authority is not well known to the rest of the world, as is the Food and Drug Administration (FDA). Japanese information is hard to access because of differences in language and culture. It is true that, the Japanese Ministry of Health, Labor, and Welfare (MHLW) is a complex organization, although any regulatory authority is by definition complex. Its ancestor, the Ministry of Health and Welfare (MHW), implemented many current regulations and Inhibitors,research,lifescience,medical decisions. Information on both organizations is

available on the Internet.2 The pharmaceutical regulatory authority of Japan is the Pharmaceutical and Food Safety Bureau (PFSB) of the MHLW. This is where the decision for application approval is formally made. Two other bodies deal with the pharmaceutical industry on a day-to-day basis. The Pharmaceuticals and Medical Devices Evaluation Center (PMDEC), usually known as “The Center,” is the actual decisionmaker for approval of new drug Inhibitors,research,lifescience,medical applications

(NDAs). The Organization for Pharmaceutical Safety and Research (OPSR), also known as “Kiko” Inhibitors,research,lifescience,medical or “the DO” (Drug Organization), is an independent body, related to the MHLW, that is in charge of discussing drug development programs with industry. A merger of these two organizations has Inhibitors,research,lifescience,medical been announced in the past few years, and would result in the creation of an equivalent to the American FDA. The three aforementioned organizations are involved in approval reviews, and the regulatory body and ultimate decision-maker is the MHLW. Although it is not a requirement, companies are strongly advised to negotiate their development programs with the DO. More detailed information can be found in Pharmaceutical Administration

and Regulations in Japan 2002, published by Japanese Pharmaceutical Manufacturers Association (JPMA) on their homepage.3 Inhibitors,research,lifescience,medical The Verteporfin in vitro structure of Japanese regulations regarding development, of pharmaceuticals is as follows: the Pharmaceutical Affairs Law (PAL), and especially its Article 14, is the organizing principle. This law is currently being revised. The MHLW implements legally binding regulations by way of ordinances. This is the way the MHLW has chosen to publish the PAL enforcement guidelines and, in 1997, to implement the guideline ICH E6, regarding GCP. Lesser regulations can be easily implemented Phosphatidylinositol diacylglycerol-lyase through publication of a “Notification of the Pharmaceutical and Medical Safety Bureau (PMSB),” which makes them not legally binding. These regulations must, be followed in order to obtain regulatory approval. This is how the guideline ICH E5 or the “ethnicity guideline” was introduced in Japan. Many other guidelines exist and, like in many other countries, older regulations sometimes coexist, with newer ones.