Page 49 - 2019食藥署年報(英文版)

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TFDA is actively improving the regulations, the amendment of Article 53-1 of the
Pharmaceutical Affairs Act ZDV HQDFWHG E\ WKH 3UHVLGHQWLDO 2UGHU RQ -XQH UHJXODWLQJ
the business undertakings engaged in wholesaling, importing and exporting of western
pharmaceuticals, their product procuring, holding and supplying related to the quality
management, organization and personnel, premises and equipment, documentation, operations
procedures, customer complaints, returns and recalls, outsourced activities, self-inspections,
transportation and other pharmaceuticals distribution practice, shall comply with the GDP
standards and pass the inspection by the central health authority, and it will obtain the western

pharmaceuticals distribution license.
In compliance with the amendments of the Pharmaceutical Affairs Act, the "Western
Pharmaceuticals Good Distribution Practice Regulations ZHUH UHOHDVHG RQ 'HFHPEHU
to be a GDP standard for drug dealers of western pharmaceuticals. The "Regulations for the
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was enacted on May 28, 2018, which clearly specify the administrative regulations on license
application for inspection.

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The "Good Manufacturers Practices Part III: Distribution" was announced on February
18, 2016 and western pharmaceuticals manufacturers must fully comply with the GDP standards
in 2019. In addition, the "Implementation schedule and procedures of Western Pharmaceuticals
Good Distribution Practice Regulations" was announced on September 11, 2018 to regulate
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requirements of the Western Pharmaceuticals Good Distribution Practice Regulations starting
from January 1, 2019.

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TFDA has progressively promoted the distribution and management system of western
pharmaceuticals since 2011, including continuing to conduct topic forums, technical seminars,
and pharmaceutical business operator’s observation learning and educational training lessons.
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actively communicated with the industry to promote relevant management policies and schedule
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