Welcome to the Adverse Event Reporting Website

According to relevant regulations, manufacturers are obliged to collect drug’s adverse event reports, and report the adverse events to relevant health authorities based on the actual situation. As required by law, any information that can identify you will be protected when data is processed in the database of drug marketing authorization holder.

An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, whether or not considered related to the medicinal product, which including an abnormal laboratory finding, symptoms (eg. headache or nausea) or physical signs (eg. rapid heartbeat, enlarged liver). AE also includes other information, such as lack of efficacy, overdose, drug interactions, etc.

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