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Food and Drug Administration
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Section 2. Management of Pharmaceutical Plant of Controlled Drugs
Current Status
According to the rules prescribed by the
Controlled Drugs Act
, the import, export, manufacturing, and
sales of Schedule 1 and Schedule 2 controlled drugs shall be implemented by the Pharmaceutical Plant
of Controlled Drugs of TFDA. Currently, the acquirement of Schedule 1 and Schedule 2 controlled drugs
by the plant involves self-production, commissioned production, or imports from other countries.
Policies and Outcomes
1. Self-production, Commissioned Production, and Imports of Schedule 1 and Schedule
2 Controlled Drugs
(1) Every dosage form of controlled drugs independently produced by the Pharmaceutical Plant of
Controlled Drugs is compliant with the PIC/S GMP regulations. A total of 10 items are self-produced,
with each item adhering to drug-specific production control standards and process standards to
ensure the quality and safe treatment of the drug. Appendix 1 Annex Table 12 provides detailed
statistics on the sales of self-produced drugs.
(2) The quantity, types, and dosage forms of controlled drugs required by various medical institutions
are increasing. The production of Schedule 1 and Schedule 2 controlled drugs with larger market
requirements has been commissioned to GMP pharmaceutical manufacturers, who are required to
maintain the same level of safety and quality management standards as the Factory for Controlled
Drugs of TFDA. TFDA has also established production monitoring specifications and dispatches
personnel to monitor production processes of the commissioned pharmaceutical manufacturers to
ensure product quality and safety. Currently, the production of five items has been commissioned to
private pharmaceutical manufacturers.
(3) To increase the number of options available for pain medication in Taiwan, an additional import item
Jurnista Prolonged-Release Tablets 8mg
was introduced in 2014. This product is a long-term pain
relief medication that releases the new chemical entity (NCE) dihydromorphenone via an osmotic
pump-controlled release system for prolonged and continuous control of pain to improve medication
convenience and adherence of cancer patients.
2. Personnel Training
To improve familiarity of Factory personnel with PIG/S GMP and controlled drugs related laws, a total
of four training sessions for Factory personnel were held in 2014.
3. New Factory Building and Renovation
The
Factory for Controlled Drugs New Building and Renovation Project
was initiated on 23 December
2014 in order to expand production capacities for Schedule 1 and Schedule 2 controlled drugs and
improve production quality. The Project is expected to be completed by the end of 2017. Once the
new factory building and renovations have been completed, production of controlled drugs shall no
longer be outsourced to ensure complete self-production.