Page 43 - 2021 Taiwan Food and Drug Administration Annual Report
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7HFKQLFDO 'RFXPHQW H&7' DQG WKH Section 3
Guidance on Taiwan Electronic Common
Technical Document (eCTD) Validation Improved the Regulations
Criteria were announced at the end of 2020. for the Distribution of
The construction of functions for submission Medicinal Products
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a link with the management of international Introduction of the Policy
medical regulations.
The Good Distribution Practice (GDP) is
II. Improvement of the trace and a measure with rigorous quality management
track system of drugs spirit to extend the Good Manufacturing
Practice (GMP) to cover the overall pharma-
,Q 7)'$ RUJDQL]HG VHVVLRQV RI ceutical supply chain and ensure the quality
PHHWLQJ IRU GLVWULEXWRUV DQG PDQXIDFWXUHUV and integrity can be maintained during the
and set up education and training programme process of delivering to the pharmaceutical
IRU KHDOWK EXUHDXV ZLWK D WRWDO RI SDU- FRPSDQLHV PHGLFDO LQVWLWXWLRQV DQG SKDU-
ticipants. The hotline and email consultation macies from the pharmaceutical factories.
VHUYLFHV UHDFKHG KDV VHUYHG D WRWDO RI
SHRSOH DQG WKH SURDFWLYH DVVLVWDQFH KDV Many organizations and countries around
helped 151 distributors and manufacturers. the globe have begun to implement the GDP
,Q WKURXJK DSSO\LQJ WKH LQIRUPDWLRQ RQ of pharmaceuticals. The Pharmaceutical
GUXJ GHFODUDWLRQV DV ZHOO DV WRJHWKHULQJ ZLWK Inspection Convention and Pharmaceutical
RQ VLWH LQVSHFWLRQV WKH FHQWUDO JRYHUQPHQW Inspection Co-operation Scheme (PIC/S) had
and local health bureaus worked together to officially announced the Good Distribution
ensure the legal of drug supply and to avoid 3UDFWLFH IRU 'UXJV LQ -XQH DQG LW KDV
misuse. become the international implementation
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III. Reinforced the drug safety implements the distribution and quality
surveillance and analysis management of drugs by promoting the GDP
V\VWHP WKDW PHHWV WKH LQWHUQDWLRQDO VWDQGDUGV
,Q WKHUH ZHUH GRPHVWLF WR HQVXUH WKH VDIHW\ RI GUXJV LPSURYH WKH
DGYHUVH GUXJ UHDFWLRQ UHSRUWV GRPHVWLF distribution quality of drugs and create
DQG IRUHLJQ GUXJV VDIHW\ DOHUW GUXJ VDIHW\ international competitiveness.
DVVHVVPHQWV DQG GUXJ ULVN FRPPXQLFD-
tion forms and 4 drug safety quarterly news- Implementation Strategy
letters were issued for raising the health care
professionals’ and the public awareness to I. Revised GDP-related regula-
ensure the safety of the public medication. tions
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