Page 14 - 2018食藥署年報(英文版)

specifications (GXP) and to be audited or inspected by the Regulatory Agency, and thereby
forming a comprehensive medicinal product life cycle management framework. To ensure study
data integrity and reliability, GLP and GCP compliance are required for non-clinical studies and
clinical trials respectively. As for the manufacturing processes, GMP shall be followed. TFDA
conducted GCP, GLP and GMP audit/inspection following international standard, and where
necessary, pre-market release inspection and analysis, as well as post-marketing sampling tests,
would be carried out to ensure continuing compliance with Good Pharmacovigilance Practice
(GPvP). These measures would improve measures for medicinal product quality and safety
surveillance and achievement of all medicinal product life cycle management objectives (Figure

1-3).

2. Controlled drugs management framework

Prescription drug abuse has been a common problem faced by various countries around the
world, suggesting that abuse or illegal distribution may lead to major damage caused by addiction
problems, which would be as serious as drug issues. Therefore, Prescription drug management is
a critical measure to prevent abuse and to ensure public health.

According to “Single Convention on Narcotic Drugs (1961),” “Convention on Psychotropic
Substances (1971)” and “Convention against Illicit Traffic in Narcotic Drugs and Psychotropic
Substances of the United Nations (1988).” Taiwan has imposed controls on narcotics, psychotropic
substances and their preparations through the “Narcotics Hazard Prevention Act.” However, due

◆Controlled drugs registration license
(institutions and businesses) ◆Addictiveness
◆Controlled drugs prescription license Licensing Scheduling ◆Dependence
(physicians and other professionals) management management ◆Abuse
◆Permit for exporting, importing and ◆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

Figure1-4 Controlled drugs management framework

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