Page 72 - Taiwan Food and Drug Administration 2016 Annual Report

Taiwan Food and Drug Adminstration

2. Risk Assessment for Medicinal Products
(1) Risk Identi?cation and Data Compilation
The following are the various passive and active monitoring mechanisms established in Taiwan that
complement each other to moniter the safety and quality of medicinal products:
a. Reporting System
A number of reporting systems for adverse drug reactions (ADR), medicinal product defects and
therapeutic inequivalence have established in Taiwan so that the healthcare professionals, the
general public and pharmaceutical companies may report such incidents accordingly. A total of
12,815 ADR cases, 943 defective drug products, and 34 therapeutic inequivalence cases were
reported in 2015.
b. Monitoring of Global Alerts
Medicinal product safety and quality alerts around the world are monitored on a daily basis in order
to immediately investigate and handle. A total of 131 drug safety alerts and 1,104 drug quality alerts
were monitored in 2015.
c. New Drug Safety Monitoring
The drug license holders of new drugs must submit periodic safety update reports during the
preliminary period after approval to monitor the safety of new drugs. A total of 356 medicinal
products are under new drug safety monitoring at the end of 2015.
d. Routine and for-cause inspection

Routine inspections are carried out at manufacturing sites of medicinal products. Where a particular
product is suspected of major quality issues, for-cause inspections will carry out accordingly.

(2) Risk Assessment Mechanism and Controls
a. Re-evaluation of Drug Safety and Risk Management

New drugs pass monitoring period and medicinal products with global safety alerts or other safety
signals will be re-evaluated.The Medicinal Product Safety Advisory Committee was established
to help clarify the safety concerns of medicinal porducts, assess the balance of clinical benefits
and risks, and suggest risk management measures such as revision of package inserts, usage
restrictions, and implementation of risk management plans. When the risks of a medicinal product
outweigh its clinical bene?ts, the product may be withdrawn from the market (by terminating the drug
license). In 2015, a total of 45 medicinal products were re-evaluated, of which risk management
measures were initiated for 17 medicinal products.
b. Medicinal Product Quality Survey
(a) In response to quality defects reports of medicinal products, the pharmatheutical companies will be
requested to investigate the root cause of drug quality problem and initiate corrective and preventive
actions (CAPA) according to GMP regulations.In the case of serious drug quality problem,the
pharmatheutical companies will be requested to submit investigation report and CAPA plans to
TFDA and initiate drug recall where necessary. In 2015, a total of 147 serious quality defects were
monitored, of which 17 medicinal products were recalled.
(b) For the medicinal product recall mechanism, pharmatheutical companies shall be requested to
conduct a product recall according to the Regulations for Medicament Recall and correct the quality
nonconformance within a limited time in response to the following : product defects reports require
product recalls, where products being recalled overseas have been imported, where post-marketing

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