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The Implementation of Good Distribution Practice (GDP) for Medicinal Products in Taiwan

【Update Date:2017-07-26unit:品質監督管理組

In order to insure the quality of medicinal products in storage and distribution, Ministry of Health and Welfare announced the Implementation Items and Schedule of the Good Distribution Practice for Medicinal Products (GDP) on 18th February, 2016. The first stage, the manufacturers and the companies who hold the drug license shall meet GDP requirements before 31st December, 2019. Taiwan Food and Drug Administration (TFDA) have implanted GDP inspection since 1st July, 2016, till 18th July, 2017, there are 148 companies pass the GDP compliance evaluation.

To improve the integrity of the quality of medicinal products, TFDA positively amend the regulation of the Pharmaceutical Affairs Act. The amendment of Article 53-1 of the aforementioned act had been approved by The Legislative Yuan, Republic of China and issued on 14th June, 2017. The law defines the companies who wholesale, import or export the medicinal products shall comply GDP. TFDA will continue amending related regulations and reaching the consensus of timetable in stage with related association, and then, accomplishes the GDP execution in Taiwan.

The inspectors play an important role in constructing a safety and quality environment of medicinal products to public. The inspectors should have an instinct like detective Holmes with careful and bold mind. Via scrutinized gathering evidences and perseverance, the inspectors will reveal the illegals. This time to reveal the illegal of Chung-long trading Co. Ltd. and Tien-Liang Biotech Co. Ltd. for tampering the medicine labels and expire date are attributed to the alerts of the inspectors whose skillful skills need many years to cultivate.

TFDA positively ensures the safe environment of using medicine by not only completing related laws and executing inspection, but also holding plenty of training and counseling activities to elevate the professional of industries. By doing so, TFDA can create a third-win situation: public, industry and government, and therefore to improve the well-being of the people.