Background Image
Table of Contents Table of Contents
Previous Page  35 / 132 Next Page
Information
Show Menu
Previous Page 35 / 132 Next Page
Page Background

2015 Annual Report

35

Controlled

Drugs

Management

Medical

Devices

Management

Risk Assessment

Management and

Research Outcomes

Cosmetics

Management

Appendix

National

Laboratory and

Testing Network

Risk Communication

and Consumer

Protection

International

Cooperation and

Cross-Strait Exchange

Medicinal

Products

Management

Policy and

Organization

Food

Management

Identifying the

Problem

Analyzing the

Problem

Solving the

Problem

Safety monitoring

Identifying potential safety problems

arising from drug use through the

spontaneous reporting system most

commonly used currently

Adverse reactions

reporting system

Regular safety reports

during medicinal product

surveillance periods

Surveillance of domestic

and global alerts

Active surveillance

systems for medicinal

product safety

Safety analysis and evaluations

Scientific methods are employed to identify

potential safety issues in the medicinal

product and evaluate its clinical benefits and

risks (signal refinement)

Risk Control

In response to medicinal product safety issues,

appropriate risk control measures must be taken

(including revision of package inserts, usage

restrictions, and withdrawing the product

from the market)

(2) New Drug Safety Monitoring

Regulations Governing Safety Monitoring of Medicines

was announced in 2004, and

safety

monitoring period

is required for new drugs. During the period of drug safety monitoring, license

holders shall collect safety information on drug used both domestically and abroad and provide

periodic safety update reports. From 2004 to the end of 2014, a total of 291 new medicines are

under new drug safety monitoring.

(3) Monitoring Domestic and Global Drug Safety Alerts

The ADR center and TFDA monitor domestic and international drug safety alerts, for issue warnings

to healthcare professional and the public. A total of 167 drug safety alerts were monitored in 2014.

(4) Proactive Drug Safety Monitoring Mechanism

The proactive assessment of drug safety mechanism was established since 2010. Such mechanisms

actively analyze the post-market drug safety of high-risk drugs by using national health insurance data

as reference for drug safety re-evaluation or planning of risk management.

2. Re-evaluation of Drug Safety and Risk Management

For drugs with safety concerns, domestic and global data were collected to reevaluate drug

safety. In 2014, there were 59 drugs re-evaluated, among them, 22 were required for risk

management measures, including 21 safety labeling changes or restricted use, Chloramphenicol

and ketoconazole oral dosage products were asked to be off the marketd due to its risk.

Figure 3-8

Procedure for post-market safety controls for medicinal products