Principles and Practice of Pharmaceutical Medicine

are kept and can be used as attached data for a new
drug application.

35.2 Japanese pharmaceutical

laws

Japanese pharmaceutical administration has a long
story;it started during the reign of Emperor Meiji,a
period during which Japan reopened its frontiers to
Western countries. The first law, enacted in 1874,
dealt with pharmaceutical sales and handling, but it
was limited to three areas (Tokyo, Osaka and
Kyoto). Fifteen years later, the law covered the
whole country and was merged with another law,-
the Patent Medicine Law, in 1925; it was then
renamed the ‘Pharmaceutical Affairs Law’ in
1943.

The Pharmaceutical Affairs Law (PAL)

The first ‘modern’ law was born in August 1960,
when it was split into the PAL and the Pharmacists’
Law. The original goal of the Law is to ensure the

quality and safety of drugs. Following the evolu-

tion of medicines, technique, quality standards and

so on, the Law was revised and amended several

times in order to incorporate new regulations, such

as the GCP. Nowadays, the PAL and the Enforce-

ment Regulations of the PAL regulate drugs from

production and development to marketing and dis-

tribution, its scope covering new drugs, quasi-

drugs, cosmetics and medical devices. It was

further revised in 1996, and the first physician

was appointed to the Regulatory Authorities in

1997. Last amendments were made in 2002 mainly
      to improve post-marketing surveillance (PMS)
      policy and revision of the approval and licensing
      systems; it includes provisions for safety measures
      for biological products, investigator-initiated clin-
      ical trials, rationalization plan to establish the
      PMDA and revision of the review system, and
      provisions related to manufacturing and distribu-
      tion business.
      The Law contains 11 chapters and 89 articles.
      Surveying this Law in brief, we observe the
      following:

Chapter 1.General provisions. Purpose of the Law

and definitions of drug, quasi-drug, cosmetic,

medical device orphan drug and pharmacy.

Pharmaceuticals & Medical Devices Agency

General Affairs

Planning & Coordination

Relief Funds

Review Administration

New Drug I

New Drug II

New Drug III

Biologics

OTC & Generics

Medical Devices

Conformity Audit

Safety

Compliance and Standards

R&D promotion

Audit

Figure 35.3 Organization of the PMDA

35.2 JAPANESE PHARMACEUTICAL LAWS 491