Chapter 2.Pharmaceutical Affairs Council. The
PAFSC is established, as well as local prefec-
tures councils.
Chapter 3.Pharmacies. Defines license standards
and supervision of the pharmacies.
Chapter 4.Manufacture and import of drugs and so
on. Here it is specified that import or manufac-
ture of a drug needs official review by the
PMDA and approval, and that the drug should
be reexamined and then reevaluated after a cer-
tain period of marketing.
Chapter 5.Selling drugs and medical devices.
Deals with licenses for sales and restrictions.
Chapter 6.Standards and tests for drugs and so on.
Establishes the JP and other standards.
Chapter 7.Handling of drugs and so on. Specifies
the handling of poisonous and powerful drugs,
drugs requiring prescription, package inserts,
containers, labeling, sales and manufacturing
restrictions.
Chapter 8.Advertising of drugs and so on. Regu-
lates advertising of drug and handling of biolo-
gical products.
Chapter 9.Supervision. Defines on-site inspection
and potential sanctions, orders for improve-
ment, cancellation of approvals and licenses,
and so on.
Chapter 9.2.Designation of orphan drugs and
orphan medical devices.
Chapter 10.Miscellaneous provisions. Deals with
data submission and the handling of clinical
trials, and so on.
Chapter 11.Penal provisions. Defines and fixes the
penalties for violation of different articles of the
Law.
The Law generally describes the frame of the reg-
ulations; for most of the articles, more details and
complementary information are provided by the
Enforcement Regulations of the PAL, which reg-
ulates most of the drug development. These regula-
tions will be reviewed in the next chapters.Other pharmaceutical laws
Separated from the main Law in 1960, the Pharma-
cists’ Law deals with the activities of pharmacists,
examination, licensing and duties; the Law con-
cerning the Organization for Pharmaceuticals and
Medical Deviceswas recently revised. Several other
laws are involved in pharmaceutical administration.
Their scope is restricted to limited areas and most of
them aim at preventing drug abuse and health
damages. They are the Poisonous and Deleterious
Substances Control Law, the Narcotics and Psycho-
tropics Control Law, the Cannabis Control Law, the
Opium Law, the Stimulants Control Law, and the
Blood Collection and Blood Donation Services
Control Law.35.3 Drug development
regulations overviewIn order to clarify the following sections, some
regulations have been artificially separated. For
Western people not familiar with Japanese regula-
tions, these rules, delivered through hundreds of
notifications from the Pharmaceutical Affairs
Bureau, are a huge maze. We have tried to simplify
this review, and we apologize for the lack of pre-
cision consequently induced.Generalities
Marketing approval, manufacturing
and import approvalTo be authorized to market a new drug in Japan, it is
necessary to obtain a drug approval and a manu-
facturing or import approval for the drug. Drug
Approval is an official confirmation, based on
scientific data, that the drug is effective and safe.
The Approval is granted for a drug to a person or a492 CH35 JAPANESE REGULATIONS