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Food and Drug Administration


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


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.