Page 62 - 2020Taiwan Food and Drug Administration Annual Report

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The short-term target has been gradually achieved: the original self-produced 1ml/bottle
injection was increased from 30,000 to 35,000 injections per batch since 2019; the original
commissioned for manufacturing 2ml/bottle of fentanyl injection has been back to self-
production in June 2019; we conducted the research and development of alfentanil injection
since 2019 and it is expected to be mass-produced after obtaining a drug license in 2021.

The medium-term and long-term targets included the initial prescription development of
morphine sulfate sustained-release capsules is completed at the end of 2019 and pilot batch
manufacturing and clinical trials will be conducted in 2020; the evaluation plan for the R&D and
production line establishment of oral solutions and patches was initiated in 2019 and the R&D
and production of new drug types will be completed. In the future, we will continue to properly
use human resource and space for the R&D and self-production of new drug types, to achieve
the goal of domestic drug production for domestic usage as well as to stably supply high-quality,
Schedule 1 and Schedule 2 controlled drugs with multiple options for the nation’s citizens.

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Introduction of the Policy
Introduction of the Polic
In recent years, the New Psychoactive Substances (NPS) had a wide range of varieties and
developed rapidly. In order to effectively monitor the NPS, TFDA had reinforced our approved
institutions’ capabilities in urine testing of illegal drugs, and collected drug abuse incident
reported through healthcare facilities and other statistics such as drug abuse urine sample tests,

tests performed with non-urine specimens in suspicious drug and controlled drug cases, drug
seized, etc., and monthly compiled into the “Drug Abuse Case and Testing Statistics” to provide
to TFDA and relevant units.

Implementation Strategy
Implementation Strate
gy
I. Reporting mechanism for healthcare facilities on drug abuse
In order to expand inspection capabilities in urine testing of NPS, TFDA invited various
approved inspection institutions to conduct introduction sessions and seminars of inspection

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