ABSTRACT
Japan operated in conformance to the Ministry of Health and Welfare (MHW) draft (Guidelines for Safety Pharmacology Studies, revised in 1999 [1]) prior to full ICH implementation. The basic principle of the revision is to harmonize the guideline with the international concepts. The working group decided to change the wording in the title from General Pharmacology to Safety Pharmacology because the objective of this guideline is to assess the safety of a test substance in humans by examining the pharmacodynamic properties of the substance (note that Japan has separate guidelines for general pharmacology [2]). The proposed guideline includes studies on vital functions as essential studies that should be performed prior to human exposure. Studies are also required to be conducted when predictable or unexpected observed effects are concerned. The working group recommended a case-by-case approach to select the necessary test items in consideration of the variable information available, which is not the primary ICH approach.
