Page 46 - 2020Taiwan Food and Drug Administration Annual Report

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Introduction of the Policy
Introduction of the Polic y

The Good Distribution Practice (GDP) is a measure with rigorous quality management
spirit to extend the Good Manufacturing Practice (GMP) to cover overall pharmaceutical supply
chain and ensure the quality and integrity can be maintained during the process of delivering to
the pharmaceutical companies, medical institutions, and pharmacies from the pharmaceutical
factories.
Many organizations and countries in the globe have begun to implement the GDP of
pharmaceuticals. The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-
operation Scheme (PIC/S) had officially announced the Good Distribution Practice for Drugs
in June 2014 , and it has become the international implementation standard for drug GDP.

Therefore, TFDA implements the distribution and quality management of drug by promoting
the GDP system that meet the international standards, to ensure the safety of drugs, improve the
distribution quality of drugs and create international competitiveness.

Implementation Strategy
Implementation Strate gy
I. Revised GDP-related regulations
To actively improve the related laws and regulations, TFDA issued an amendment to Article
53-1 of the Pharmaceutical Affairs Act under the Presidential Decree on June 14, 2017. The

regulations specify that business engaged in the wholesaling, importing and exporting of western
medicines should meet the requirements in the “Western Pharmaceuticals Good Distribution
Practice Regulations,” and their businesses can only be implemented after passing the inspection
and obtaining the western pharmaceuticals distribution license by the central health competent
authority.
In line with the amendment to the Pharmaceutical Affairs Act, the “Western
Pharmaceuticals Good Distribution Practice Regulations” were released on December 28,
2017 as the standard for Western pharmaceuticals dealers. Furthermore, the “Regulations for the
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were stipulated and released on May 28, 2018, to specify the management regulations for
inspection application and issuance of licenses.

II. Implementation timeline of GDP
On February 18, 2016, the Ministry of Health and Welfare announced that manufacturers

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