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2015 Annual Report
37
Controlled
Drugs
Management
Medical
Devices
Management
Risk Assessment
Management and
Research Outcomes
Cosmetics
Management
Appendix
National
Laboratory and
Testing Network
Risk Communication
and Consumer
Protection
International
Cooperation and
Cross-Strait Exchange
Food
Management
Medicinal
Products
Management
Policy and
Organization
To strengthen management of controlled drugs used for medical and scientific purposes in Taiwan, TFDA
has established regulations, certification, and distribution management of controlled drugs as well as
management systems for early-warning monitoring and abuse prevention. Total-quality validation was also
implemented for Factory of Controlled Drugs in order to improve the quality of medicinal products and to
prevent abuse or illegal use of controlled drugs.
Section 1. Controlled Drugs Regulations and DistributionManagement
Current Status
Drug abuse is a common problem around the world. Improper use of addictive controlled drugs or
its illegal distribution makes such drugs as dangerous as illegal drugs. TFDA referred to the United
Nations' Single Convention on Narcotic Drugs, Convention on Psychotropic Substances and the
Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substance, to control narcotic
drugs, psychotropic substances and their preparations via the
Narcotics Hazard Prevention Act
.
However, some of the drugs and substances may offer medical or scientific research value, and
would hence be classified as a controlled drug. The
Controlled Drugs Act
is used as the legal
reference, making use of license management, scheduling management, and diversion management
(Figure 4-1) as the control framework to manage controlled drugs used for medical purposes or
scientific research while preventing their abuse and illegal use.
4
Habitual use
Dependence
Abuse
Danger to the
society
Recording
Reporting
Health authorities
Audits and Inspection
Institutions
Controlled drugs
registration license
(Institutions and businesses)
Controlled drugs
prescription license
(Doctors and professionals)
Export, import, and
manufacturing permits
(source management)
Relevant licenses: transportation permit,
letter of approval for medical education,
research, and test purposes
License
Management
Diversion
Management
Schedule
Management
Controlled Drugs Management
Figure 4-1
Controlled drugs management framework