Page 46 - 2017食品藥物管理署年報(英文版)

2017 Taiwan Food and Drug Administration Annual Report

(2) Supply of schedule 1 and 2 controlled drugs
A. 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$ 670,480,000 in 2016. Refer to Table 5 of Annex II for statistics for the
revenue of Pharmaceutical Plant of controlled drugs.
B. For Schedule 1 and Schedule 2 controlled drugs with greater demands in
medical institutions, the market is commissioned to domestic pharmaceutical
manufacturers that have met GMP regulations, under the conditions that the said
manufacturers must enforce safety and quality management measures aligned

with those of Pharmaceutical Plant of Controlled Drugs.
C. To provide more diverse selection for pain management during treatment, TFDA
developed new chemical entities (NCE), new administration paths and new
dosage forms of opioids according to the needs of the medical institutions and
patients. In 2016, 10/20mg long-lasting Oxycodone tablets, 5mg quick-acting
capsules and 75μg/hr Fentanyl transdermal patch was imported for the first time
to benefit patients suffering from severe pain.

(3) Continuing Improvement to Product Quality and Standards of Pharmaceutical
Plant of Controlled Drugs
A. 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, and were rewarded for the next two years.
B. Post-market tracking studies were carried out for “Morphine Sulfate - 15 mg” to
ensure product quality, safety, and therapeutic efficacy.
C. On-job-training for personnel was enhanced for PIC/S GMP, controlled drugs,

and pharmaceutical affair management.

(4) Building new PIC/S GMP factories
To expand independent production capacities for Schedule 1 and Schedule 2
controlled drugs and improve product quality, TFDA initiated the “New Production
Building Construction and Renovation Project for Pharmaceutical Plant of Controlled
Drugs” since 2014. The new factory building was set for completion in 2017 and shall be

used for production purposes after passing PIC/S GMP assessments.

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