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Food and Drug Administration


c. New Drug Safety Monitoring

For new drugs, periodic safety update reports (PSUR) must be submitted during the early stages of

market release to monitor new drug's safety profile. As of the end of 2014, a total of 291 new medicines

are under new drug safety monitoring.

d. Post-market Surveillance Plan

Commercially avalaible medicinal products are selected for sampling analysis according to the risk

levels involved. In 2014, a total of 90 medicinal products with suspect therapeutic effectiveness

such as soporific drugs containing Zolpidem, diabetes medication containing Metformin, and

painkillers containing Piroxicam were sampled for testing. Of these, three medicinal products failed

the test. The responsible pharmaceutical companies were ordered to recall the products and make

improvements within a specified period.

(2) Risk Assessment Mechanism and Control

a. Re-evaluation of Drug Safety and Risk Management

(a) Medicinal Product Safety Consultation Team

A Medicinal Product Safety Advisory Committee was established to assess severe cases reported

such as deaths, new drugs passed monitoring period, global medicinal product alerts, and other

medicinal products with safety signal. The Medicinal Product Safety Advisory Committee helps

clarify new safety concerns of medicinal products, assesses the balance of clinical benefits and

risks, and suggests risk management measures such as label changes, restricts the clinical use, or

request the sponsor to implement risk management plans. When the risks of a medicinal product

outweigh its clinical benefits, the product may be withdrawn from the market (by terminating the

drug permit license).

(b) Re-evaluation of Drug Safety and Risk Management

In 2014, a total of eight Medicinal Product Safety Advisory meetings were held to re-evaluate the

safety of 59 medicinal products. Of these, 22 products were subject to risk management measures,

including 21 revisions of the product label or restricted clinical use as well as the requirement for

implementing risk management plans for two medicinal products, and termination of drug permit

licenses for orally administered antibiotics containing Chloramphenicol and Ketoconazole as the

risks outweigh the clinical benefits.

b. Medicinal Product Quality Inspections

Investigations and corrective actions were implemented for defective drug product reports. For

defective products with high levels of concern or high frequency, the responsible pharmaceutical

company must submit an investigation report for the causes of abnormal quality as well as

preventive and corrective actions. Where necessary, drug recalls must be required out as well.

Under the medicinal product recall mechanism, pharmaceutical companies must follow the

Regulations for Medicament Recall and carry out recalls in the following situations: defective

product evaluation results; the product is imported and is being recalled in other countries; post-

market sampling results fail to meet specifications; on-site inspections have identified quality

concerns; or the pharmaceutical company voluntarily initiates a recall. Companies involved are

required to correct quality abnormalities within the limited time as necessary. In 2014, a total of 150

defective products were monitored. Among these, 11 medicinal products had to be recalled after

evaluation, while 86 medicinal products had to be recalled due to quality concerns.