Page 14 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

2. Controlled drug management framework

Drug abuse has been a common problem which is faced by various countries around
the world. Therefore, the control of addictive drugs becomes more important. At the
same time, TFDA prevents controlled drugs from abusing or illegal distributing with
vigilance monitoring, abuse prevention and control measures to ensure the physical and
mental health of fellow citizens and promote social stability.
According to the “Single Convention on Narcotic Drugs”, “Convention on
Psychotropic Substances”, and the “Convention against Illicit Traffic in Narcotic Drugs

and Psychotropic Substances of the United Nations” , Taiwan has imposed controls
on narcotics, psychotropic substances, and their preparations through The “Narcotics
Hazard Prevention Act”. However, due to the necessity of controlled drugs in medical
applications or scientific research, the “Controlled Drugs Act” has been established to
give a control framework which is composed of license, scheduling, and distribution
management (Figure 1-4).

◆Controlled drugs registration license
(institutions and businesses) ◆Addictiveness
◆Controlled drugs prescription license ◆Dependence
(physicians and other professionals) License Schedule ◆Abuse
◆Permit for exporting, importing and management management ◆Social risks
manufacturing (source management)
◆Relevant licenses: transportation permit,
letter of approval for medical education,
research and trial purpose
Diversion
management

Institutions Health authorities
Recording Reporting Inspection

Figure 1-4 Controlled dugs management framework

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