Page 16 - 2019食藥署年報(英文版)

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Unlike general consumer products, medicinal products are closely associated with the
health and lives of fellow citizens. Medicinal products are therefore subject to strict regulations
and must acquire drug permit licenses from the central competent health authority before they
may be sold on the market. TFDA is constantly improving the review process and strengthening
medicinal product monitoring systems to ensure the supplies of safe and quality drugs amongst
the general public by revising pharmaceutical laws, harmonizing with international standards,

establishing expedited review processes and monitoring the sources, distribution and quality of
drug manufacturing, thus prohibiting illegal drug distributions , and enforcing controlled drug
managements.
The life cycle of medicinal products from research and development to marketing,
including preclinical validation, clinical trial, pre-market application, production and post-
market surveillance shall be in compliance with various good operating practices. Therefore,
TFDA has established a comprehensive medicinal product life cycle management by the

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