Page 17 - 2023 Taiwan Food and Drug Administration Annual Report
P. 17
1Organization
and Policies
illegal drugs, and pharmaceutical vendors hazards.
and product circulation management. All the According to the “Controlled Drugs
measures aim to ensure the safety, efficacy,
and quality of medicinal products, to increase Act,” controlled drugs are categorized into
timely access to medicine for people in four categories: their potential for habitual use,
need, to facilitate the development of the dependence, abuse, and danger to society. The
biotechnology industry in Taiwan, and hereby source management of various types of users (such
create a win-win situation among consumers, as institutions, industry operators, physicians,
industries, and the government. dentists, veterinarians, or veterinary assistants) is
conducted through certifications such as controlled
II. Controlled drugs drug registration certificates, use licenses, and
management framework export, import, and manufacturing agreements. The
flow management is also strengthened, requiring
Controlled drugs refer to addictive narcotic users to register and declare the income, expense,
drugs, psychotropic drugs, and other drugs and balance of controlled drugs in ledgers, to
believed to require regulations and may only be prevent the use or abuse of controlled drugs. Its
used for medical and scientific purposes. If used management structure is shown in Figure 1-6.
improperly or illegally, they can easily cause health
Registration Reporting Inspection • Registration certificate of
controlled drug
Institutions Health authorities
(institutions, business operators)
Four schedules of management Diversion Licensing
according to addictiveness, management system • License of controlled drug
dependence, abuse, and social
risks. Level 1 is relatively risky. Schedule (dentists, physicians and veteri-
management narian)
• Permit for exporting, import-
ing and manufacturing
(source management)
• Relevant license: transporta-
tion permit, letter of approval
for medical education,
research and trial
Figure 1-6 Management structure of controlled drugs
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