title: Safety regulation for medicines and foodstuffs.
abstract: In Japan, for medicines we have the Pharmaceutical Affairs Law and for food the Food Sanitation Law, these two being applied appropriately for security management. The range of test data needed to be obtained by examination is prescribed by the laws, and each test method is notified in the form of guidelines which are regularly revised in line with progress in science and technology and international harmony. With medicines, a monitoring system is always maintained also after marketing, taking account of the existence of side effects along with efficacy.
authors.affiliation: Osaka City University, Graduate School of Medicine, Abeno-ku, Osaka, Japan.
authors.forename: Yoshinobu
authors.initials: Y
authors.lastname: Hirayama
mesh_terms: D017408:Guidelines as Topic; D006801:Humans; D007564:Japan; D007880:Legislation, Drug; D007881:Legislation, Food; D004364:Pharmaceutical Preparations / Q000592:standards*; D018570:Risk Assessment; D012308:Risk Management; D012449:Safety
chemical_list: D004364:Pharmaceutical Preparations