ABSTRACT
Pharmaceutical administration in Japan is based on
various laws and regulations, consisting mainly of (i)
Pharmaceutical Affairs Law, (ii) Pharmacists Law, (iii)
Organization for Pharmaceutical Safety and Research
Law, (iv) Blood Collection and Blood Donation Services
Control Law, (v) Poisonous and Deleterious Substances
Control Law, (vi) Narcotic and Psychotropic Control Law,
(vii) Cannabis Control Law, (viii) Opium Law, and (ix)
StimulantsControl Law. For the enforcement andmanage-
ment of these laws, detailed regulations are prepared by
the government in the form of ministerial ordinances and
notices, such as the Enforcement Ordinance and the
Enforcement Regulations of the Pharmaceutical Affairs
Law, and notifications are issued by the Director General
of the Bureau or by the directors in charge of the Division
in the MHLW.
