Page 99 - 2024 Taiwan Health and Welfare Report

07 ｜ Management of Food and Drug

Section 2 Source Management for doses transported under temperature out of
approved range.
Medicinal Products
(3) The results of the pharmaceutical quality
1. As of the end of 2023, the numbers of domestic
and imported drug product manufacturers and investigation and monitoring for 2023 are shown
active pharmaceutical ingredient manufacturers in in Table 7-5.
compliance with the GMP regulations formulated in 2. Since its establishment in 2010, the task force
accordance with PIC/S (Pharmaceutical Inspection for combating counterfeit and substandard drugs
Cooperation Scheme) standards are detailed in has witnessed a significant decrease in the annual
Table 7-4. average seizure rate, dropping from the initial rate
2. As of the end of 2023, a total of 1,010 manufacturers of 11.81% to 1.60% in 2023, as shown in Figure
and distributors have obtained GDP (Good 7-3. In 2023, the health authorities handled a total
Distribution Practice) permits for distribution of 10,525 cases of non-compliant advertisements
operations in compliance with GDP regulations. related to food, drugs and cosmetics. The total
amount of fines imposed amounted to NTD 432
Section 3 Supply Chain Monitoring for million. The violation rate in advertisements for 2023
Drugs was 9.19%, as shown in Figure 7-4.
1. Drug Quality Monitoring Section 4 Management of Drug Safety
(1) In 2023, TFDA received 935 reports of alleged 1. Pharmaceutical Safety Monitoring in 2023: Received
quality defects in total, out of which 26 cases 13,357 domestic adverse drug reaction (ADR)
have been chosen for recall (including voluntary reports, monitored 95 domestic and international
notifications from manufacturers). Additionally, drug safety alerts and 9 COVID-19 vaccine safety
TFDA has actively monitored 1,368 foreign drug alerts, conducted safety re-evaluation of 53 new
quality alerts and selected 39 relevant alerts to medicinal products after five years post-market
be published under the "Notification and Safety safety monitoring and issued 11 drug safety
Watch Section" of the TFDA's website. communications to provide information to patients
(2) In 2023, 583 batches of biologics, a total of and health care professionals about new safety
27,846,492 doses were inspected and sealed. issues.
TFDA rejected 4 batches comprising 8,506

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

Domestic Overseas
Manufacturers Manufacturers Manufacturers
Category of western Manufacturers Logistics Pilot of medicinal of western Manufacturers
pharmaceutical of APIs Plants Plants gases pharmaceutical of APIs
products products
Numbers 144 29 26 9 31 958 887
Source: Taiwan Food and Drug Administration

Table 7-5 Results of Drug Quality Monitoring in 2023

No. of Compliant Compliance
Tested Items
reported case cases rate (%)
Quality monitoring (including nitrosamine impurities) for oral tablet
formulations containing Chlorpheniramine maleate and 7 other 54 54 100%
ingredients.

Source: Taiwan Food and Drug Administration

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