Pharmacovigilance in Taiwan | PSUR | Adverse Events | Medical Devices | Regulatory Doctor

Pharmacovigilance in Taiwan.

Pharmacovigilance in Taiwan

WHO defines the term ‘pharmacovigilance’ as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.” During the first five years of a new drug being put on the market, pharmacovigilance is particularly important, as comparatively little about its safety profile is known until it is exposed to a much larger population. The Bureau of Pharmaceutical Affairs (BPA), Department of Health (DOH), Taiwan, has implemented numerous pharmacovigilance activities in recent years. Our ultimate goal is to enhance drug safety, hence to promote public health.

Medical Devices

With the increasing life expectancy and attention to health, the use of medical devices increased rapidly. Medical devices related adverse events were also becoming an important issue. Therefore, the National Medical Device Adverse Event Reporting System was set up in 2002.

The reporting of adverse events of medical devices is regulated by article 45 and article 45-1, Pharmaceutical Affairs Act, as well as the Regulation of Reporting Serious Adverse Reactions and Regulation of Medical Products under Monitoring as drugs. However, the surveillance period of medical device is usually 3 years after the license was issued unless announced individually.

Serious adverse event (SAE) Report for Investigational medical devices under Pre-marketing clinical trials is according to Medical Device Good Clinical Practice which is amended on the 17th May 2007.

We also have a computerized database to integrate related reports. For further information, please check our website:


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