Page 16 - 2020Taiwan Food and Drug Administration Annual Report
P. 16
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I. Medicinal products management framework
In the life cycle management of medicinal products, from product development, preclinical
trials, clinical trials, marketing application, manufacturing to marketing, etc., various good
operating practices must be followed. Different from general consumer goods, medicines can
only be sold on the market after obtaining a marketing authorizations issued by the central
health authority. In order to ensure the safety of the public, TFDA continues to strengthen the
quality management policy throughout the drug life-cycle (Figure 1-5) by the international
harmonization of regulatory management, the establishment of various priority review
mechanisms, digital management, standardization of quality and safety surveillance, inspection
of illegal drugs, management of pharmaceutical vendor and drug circulations, etc. All of these
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them as soon as possible. These measures can also promote the development of biotechnology
industry in Taiwan and create a win-win situation for patients, business owners, and the
government.
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