Page 97 - 2023 Taiwan Health and Welfare Report

07 Management of Food and Drug 07

Section 2 Source Management for doses. TFDA rejected 5 batches comprising
Medicinal Products 238,639 doses transported under temperature
out of approved range.
1. As of the end of 2022, the number of manufacturers
(3) The results of the pharmaceutical quality
that obtained the approval letter of PIC/S GMP,
investigation and monitoring for 2022 are shown
including manufacturers of western pharmaceutical
in Table 7-5.
products and APIs, are provided in Table 7-4.
2. Since its establishment in 2010, the task force
2. As of the end of 2022, a total of 940 pharmaceutical
for combating counterfeit and substandard drugs
companies in the manufacturing and wholesaling
has witnessed a significant decrease in the annual
sectors have obtained the western pharmaceuticals
average seizure rate, dropping from the initial rate
distribution license.
of 11.81% to 2.47% in 2022, as shown in Figure
Section 3 Supply Chain Monitoring for 7-3. In 2022, the health authorities handled a total
Drugs of 6,889 cases of non-compliant advertisements
related to food, drugs and cosmetics. The total
1. Drug Quality Monitoring
amount of fines imposed amounted to NTD 259
(1) In 2022, TFDA received 708 reports of alleged
million. The violation rate in advertisements for 2022
quality defects in total, out of which 39 cases
was 9.67%, as shown in Figure 7-4.
have been chosen for recall (including voluntary
notifications from manufacturers). Additionally, Section 4 Management of Drug Safety
TFDA has actively monitored 1,714 foreign drug 1. Drug safety monitoring in 2022: TFDA received
quality alerts and selected 38 relevant alerts to 13,339 domestic adverse drug reaction reports,
be published under the "Notification and Safety monitored 97 domestic and foreign drug safety
Watch Section" of the TFDA's website. alerts, 45 COVID-19 vaccine safety alerts,
(2) In 2022, 493 batches of biologics, a total of conducted 49 drug safety assessments, and
46,485,991 doses were subjected to testing and published 16 drug risk communication forms.
sealing, encompassing a quantity of 46,485,991

Table 7-4 Number of Manufacturers that Obtained the Approval Letter of PIC/S GMP

Domestic Overseas
Manufacturers Manufacturers
of western Manufacturers Logistics Pilot Manufacturers of western Manufacturers
Category of medicinal
pharmaceutical of APIs Plants Plants pharmaceutical of APIs
products gas products
Numbers 149 29 25 8 30 958 859
Source: Taiwan Food and Drug Administration

Table 7-5 Results of Drug Quality Monitoring in 2022

No. of Compliant Compliance
Tested Items
reported case cases rate (%)
Surveillance on the quality of marketed oral preparations of generic
drugs that active ingredients are not under pharmacovigilance with 32 32 100
a narrow therapeutic index
Source: Taiwan Food and Drug Administration

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