Page 43 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

Chapter 3. Controlled Drugs Management

In order to strengthen management of controlled drugs used for medical and scientific
purposes in Taiwan, TFDA has established management systems that include regulations,
certification, distribution management of controlled drugs as well as early warning, monitoring,
and abuse prevention. Total quality validation was also implemented for the Factory of Controlled
Drugs in order to improve drug quality and to prevent abuse or illegal use of controlled drugs. Usage
for Schedule 1 and Schedule 2 controlled drugs has been increasing because of Taiwan's aging Part II - Key Administrative Results Controlled Drugs Management
society and increased incidence of various diseases. There was also a drastic growth in the
use of sedatives and hypnotics in Taiwan, which was accompanied by incidents of improper
prescriptions. In order to prevent improper or illegal use of controlled drugs, management of
controlled drugs must be strengthened accordingly.

Section 1. Controlled Drugs Regulations and Distribution Management

Current Status
Drug abuse is a common problem faced by various countries around the world. Improper
use of addictive controlled drugs or its illegal distributions make such drugs as dangerous as
illegal drugs. Taiwan has imposed controls on narcotics, psychotropic substances, and their
preparations 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. The Narcotics Hazard Prevention Act was also established
to enforce stringent controls. However, some drugs and substances are classi?ed as controlled
drugs because of their usefulness in medical applications or scienti?c research, and are subject
to the provisions of the Controlled Drugs Act and a control framework composed of license,
scheduling, and distribution management (Figure 2-3-1).

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

Institutions Health authorities
Recording Reporting Inspection

Figure 2-3-1 Controlled drugs management framework

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