Page 46 - Taiwan Food and Drug Administration 2016 Annual Report

T
Taiwan Food and Drug Adminstrationaiwan Food and Drug Adminstration

2. Continuing Improvement to Product Quality and Standards of Pharmaceutical Plant of
Controlled Drugs
(1) The Morphine Sulfate Sustained Release FC Tablets - 30 mg were rewarded with the Symbol of
National Quality (SNQ) in the modern pharmaceuticals category in 2014 as well as in 2015.
(2) Post-marketing tracking studies were carried out for Morphine Sulfate - 15 mg to ensure
product quality, safety, and therapeutic efficacy.
(3) On-job-training for personnel was enhanced for PIC/S GMP, controlled drugs, and medicinal
product management
3. Building New PIC/S GMP Factories
To expand independent production capacities for Schedule 1 and Schedule 2 controlled drugs
and improve product quality, the TFDA initiated the New Production Building Construction and
Renovation Project for Pharmaceutical Plant of Controlled Drugs. Every step of the construction
project monitored closely which allowed the progress to be slightly ahead of schedule. The
new factory building was set for completion in 2017 and shall be used for production purposes
after qualifying PIC/S GMP assessments in order to supply public and medical institutions with
Schedule 1 and Schedule 2 controlled drugs they require.

Section 3. Controlled Drug Alerts and Monitoring

Current Status
Drug abuse is becoming an increasingly global and complex challenge. Abuse of illegal
drugs gravely affects physical and mental health, economic development, social stability, public
security, and may even impact overall national competitiveness.
To effectively prohibit and prevent drug abuse and build a healthy society well-protected from
the hazards of narcotics, prevention must be regarded as the main goal of policies for preventing
drug abuse which shall start with source management and early warning systems.
Core activities include compilation of drug abuse reports and information, establishing a
comprehensive early warning system, enhancing management efforts for controlled drugs, and
strengthening regional strategic alliances against drug abuse in order to achieve early warning
functions and eliminate rampant drug abuse in Taiwan.

Policies and Outcomes

1. Collecting and Compiling National Drug Abuse Information
To get an insight to status of domestic drug abuse and control the medication patterns
in Taiwan, monitor current status of national drug abuse, and identify trends drug abuse
behaviors, statistics such as drug abuse urine tests, non-urine tests of suspected drugs and
controlled drugs cases, and discovery of illegal drugs in the Taiwan region shall be compiled to
form the Drug Abuse Cases and Testing Statistics.

2. Notification on the Prevention of Controlled Drugs Abuse
(1) To achieve effective understanding of epidemic trends in the abuse of controlled drugs, the
TFDA established the Drug Abuse Reporting System (http://dars.fda.gov.tw/) that compiles
analyses and report data every month. In 2015, a total of 18,399 drug abuse cases were
reported by medical institutions. The top 3 drug abuse categories were heroin with 11,697
individuals (63.6%), (meth) amphetamine with 5,672 individuals (30.8%), and ketamine with
44
44
1,556 individuals (8.5%).