Page 45 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

4. Management of Controlled Drugs Inspection
Refer to Table 13 of Annex I for detailed statistics of controlled drug inspection carried out in
2015. Institutions that exhibited relatively higher growth or usage quantities of prescriptions
of hypnotics issued in 2013 were screened and selected for the inspection process. 237
institutions were audited. 25 were found to be nonconforming with a violation rate of 10.55%,
including 2 cases of medical improper prescriptions. The said violations were penalized
according to the relevant laws.
5. Training for Controlled Drugs
To improve familiarity with laws and management practices related to controlled drugs amongst Part II - Key Administrative Results Controlled Drugs Management
local health agencies, a total of three basic courses and two advanced courses on controlled
drug management and laws were held in 2015. These courses were attended by a total of 442
individuals.

Section 2. Pharmaceutical Plant of Controlled Drugs Management

Current Status
According to the Controlled Drugs Act, import, export, manufacture, and sales of Schedule
1 and Schedule 2 controlled drugs can only be carried out by the TFDA Pharmaceutical Plant of
Controlled Drugs. The mission of the Pharmaceutical Plant of Controlled Drugs is to meet the pain
control medical requirement of Schedule 1 and Schedule 2 controlled drugs, and to supply the
relative pharmaceutical products during disasters and emergency mobilization.
The TFDA Pharmaceutical Plant of Controlled Drugs must comply with PIC/S GMP as well
as regulations pertaining to the management, production, distribution, and loss of controlled drugs
provided in the Controlled Drugs Act in order to ensure the quality and safety of the controlled drugs.

Policies and Outcomes
1. Supply of Schedule 1 and Schedule 2 Controlled Drugs
In order to provide a sufficiency of Schedule 1 and Schedule 2 controlled drugs needed
by medical services in Taiwan, Pharmaceutical Plant of Controlled Drugs apply three main
methods of self-production, commissioned production, and imports. The following lists the
outcomes of such measures:
(1) Pharmaceutical Plant of Controlled Drugs independently produces nine products in compliance
with the PIC/S GMP specifications to ensure product quality, safety, and therapeutic efficacy.
The turnover from selling drugs amounted to NT$ 586,406,000 in 2015. Refer to Table 14 of
Annex I for statistics for the revenue of Pharmaceutical Plant of controlled drugs.
(2) Production for a total of five Schedule 1 and Schedule 2 controlled drugs with greater demands
in medical institutions and the market was commissioned to domestic pharmaceutical
manufacturers that have demonstrated excellent performance, under the conditions that the
said manufacturers must enforce safety and quality management measures aligned with those
of Pharmaceutical Plant of Controlled Drugs.
(3) To provide more diverse selection for pain medication during treatment, the TFDA developed
new chemical entities (NCE), new delivery paths, and new dosage forms of opioids according
to the needs of the medical institutions and patients. In 2015, the fentanyl buccal soluble films
was imported for the first time as an acute moderate to severe painkiller agent, benefiting
patients suffering from severe pain.

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