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Food and Drug Administration


(2) Continuing the Monitoring of Illegal Medicinal products, Food Products, and Cosmetics on the Market

a. In 2014, a total of 721 illegal medicinal products were found. A total of 508 cases were brought to justice,

while administrative actions were imposed for 37 of these cases, with fines totaling TWD 865,000.

b. Measures such as interministerial collaboration, simplified procedures, and improved supervision

of health agencies have been implemented. A total of 3,068 cases of illicit food product, medicinal

products, and cosmetics advertisements were found in 2014, with fines totaling TWD 94.089 million.

c. Joint Audit Project of Illegal Medicinal products and Cosmetics

In addition to strengthened management of active pharmaceutical ingredients (APIs) produced by

upstream pharmaceutical companies, improved auditing was also conducted for downstream sales

and distribution channels. News reports were also aired at appropriate occasions to form effective

deterrence against the sales channels of illegal businesses. In 2014, a total of five joint audit projects

of illegal medicinal products and cosmetics were implemented (Table 3-3). A total of 142 violators

were identified. Major violations included: sales of prescription medicine without prescription, provision

of medicinal products by non-pharmacists, improper records for controlled drugs, retail display of

prescription drugs, sales of orally administered drugs containing alcohol by non-pharmaceutical

companies (such as betelnut stands, Internet cafes, and convenience stores), and retail display,

dispensing, or supply of inferior drugs, with fines totaling TWD 2.118 million.

Section 4 Medicinal Products Safety Management

Current Status

Medicinal products with unknown or unexpected risks have been identified in recent years. This has

given rise to urgency for enacting effective controls of post-market safety of medicinal products and

establishing a comprehensive post-market safety surveillance system and legal context (Figure 3-8).

Policies and Outcomes

1. Strengthened Medicinal Product Safety Surveillance

(1) Adverse Drug Reaction Reporting System

The National Adverse Drug Reactions (ADRs) Reporting System was established in 1998. In 2014, a

total of 11,399 cases were reported to this system.

Month of


Project audit items


March Medicinal product audit project (prescription

medicine and pharmaceutical company licenses)

A total of 31 pharmacies, pharmaceutical companies,

betelnut stands, or Internet cafes was audited. A total of 12

violators were found


Pharmacist audit project (prescription medicine

and dispensing of controlled drugs)

A total of 618 pharmacies, drugstores, and clinics was

audited. A total of 73 violators was found for a total of 75


June Orally Administered Western Medicine Containing

Alcohol Audit Project

A total of 105 betelnut stands were audited, with 14 violations

being the sales of orally administered drugs containing


August to


Medicinal Product Audit Project (prescription

medicine and inferior drugs)

A total of 173 pharmacies, clinics, and hospitals was audited.

A total of 21 violators was found

October Antibiotics Audit Project

A total of 41 pharmacies was audited. A total of 22 violators

was found

Table 3-3

Results of joint audits for illegal medicince products and cosmetics