Page 41 - Taiwan Food and Drug Administration 2016 Annual Report

2016 ANNUAL
REPORT

may still surface after marketing due to inherent limitations of clinical trials. Therefore it is an
important matter to establish comprehensive post-marketing safety monitoring systems and legal
environments for medicinal products (Figure 2-2-6).

Safety monitoring Adverse Drug Reactions Reporting System
Finding
the Detecting potential safety problems of medicinal
Problem products by using some methods like most used
spontaneous reporting system Periodic Safty Update Reports during drug safety
monitoring peroide

Analyzing Safety analysis and evaluations Proactive Drug Safety Monitoring Mechanism
the Part II - Key Administrative Results Medicinal Products Management
Problem Identify potential safety issues by scientific methods
and evaluate the balance between clinical benefits
and risks of medicinal products (signal refinement) Monitoring Domestic and Global Drug Safety Alerts

Risk Controls
Solving
the In response to medicinal product safety issues,
Problem appropriate risk control measures shall be taken
(such as revision of package inserts, usage restrictions,
and withdrawing the product from the market)

Figure 2-2-6 Procedure for post-marketing safety monitoring and risk management of medicinal products

Policies and Outcomes
1. Strengthened Medicinal Product Safety Surveillance
(1) Adverse Drug Reaction Reporting System
The Adverse Drug Reaction (ADR) Reporting System was established in 1998, allowing
healthcare professionals, the public, and pharmaceutical companies to report any suspected
cases of ADRs. A total of 12,815 ADR reports were received in 2015.
(2) New Drug Safety Monitoring
The Regulations for Drug Safety Monitoring was promulgated in 2004, and stipulated that
medicinal product lisence holders of new drugs must submit periodic safety update reports
during the preliminary period after approval. A total of 356 medicinal products are under new
drug safety monitoring at the end of 2015.
(3) Monitoring Domestic and Global Drug Safety Alerts
Drug safety alerts from Taiwan and overseas are monitored on a daily basis. Where necessary,
early warnings as well as re-evaluation of drug safety shall be initiated accordingly. A total of
131 safety alerts were monitored in 2015.
(4) Proactive Drug Safety Monitoring Mechanism
The Proactive Drug Safety Monitoring Mechanism was sequentially established since 2010
realizing the safety profile of medicinal products with important potential risks in Taiwan in
order to provide a reference for drug safety re-evaluations and determining risk management
measures. Overall safety analysis projects were carried out for 10 medicinal products in 2015.

2. Re-evaluation of Drug Safety and Risk Management
Dosmetic and international information related to medicinal products with suspected safety
issues were compiled to re-evaluate drug safety and initiate risk management measures
if necessary. In 2015, a total of 45 medicinal products were re-evaluated, of which risk
management measures were initiated for 17 medicinal products, such as revision of package
inserts, usage restrictions. 39