Page 106 - 2022 Taiwan Health and Welfare Report

▏Section 2 Source Management for Medicinal Products
Following the Pharmaceutical Affairs Act, both domestic and overseas pharmaceutical manufacturers (including API) shall comply with the PIC/S GMP Guide. The number of manufacturers that obtained the approval letter in 2021 is shown in Table 7-4.
▏Section 3 Supply Chain Monitoring for Drugs
1.As of the end of 2021, pharmaceutical companies of the western pharmaceutical products that require cold chain storage and transportation have implemented the GDP for Medicinal Products completely. A total of 89 pharmaceutical companies obtained the western pharmaceuticals distribution license.
2. Drug Quality Monitoring
(1) In 2021, TFDA received 893 reports of alleged quality defects in total. After thorough assessment, 47 have been chosen for recall (Including the actively report from manufacturer). TFDA has actively monitored international drug quality alerts for 1,470 items and selected 57 relevant alerts to be published under the "Notification and Safety Watch Section" on TFDA's website.
(2) In 2021, the TFDA completed lot release for 523 batches, totally 56,649,049 doses of biologics. TFDA successfully blocked three batches containing a total of 48,157 vials of noncompliant vaccines based on their records for temperature during transit.
(3) The drug quality monitoring results for 2021 are shown in Table 7-5. The unqualified products were handled as required by law.
Table 7-4 Number of manufacturers that obtained the approval letter of PIC/S GMP
Source : Taiwan Food and Drug Administration
Table 7-5 Results of Drug Quality Monitoring in 2021
Domestic
Overseas
Category
Manufacturers of western pharmaceutical products
Manufacturers of APIs
Logistics plants for Western medicine
Pilot plants for Western medicine
Manufacturers of medicinal gases
Manufacturers of western pharmaceutical products
Manufacturers of APIs
Numbers
146
28
24
11
30
974
831
Tested Items
No. of reported case
Compliant cases
Compliance rate (%)
Quality monitoring of medication of Triple H (Hypertension, Hyperglycemia, Hyperlipidemia): oral preparations of antihypertensive drugs (containing Valsartan), hypolipidemic drugs (containing Atorvastatin and Pitavastatin), and hypoglycemic drugs (containing Acarbose).
82
80
97.6
104
Source : Taiwan Food and Drug Administration