Page 42 - 2021 Taiwan Food and Drug Administration Annual Report
P. 42

entry of counterfeit drugs into the legitimate            2FWREHU          
    VXSSO\ FKDLQ   $W WKH VDPH WLPH  LW FRQWLQXHV         (II) To assist pharmaceutical companies to
    to enhance and expand the functions of the
    online submission system for drug registra-               GHFODUH WKH WUDFH DQG WUDFN GDWD  7)'$ KDV 
    WLRQ   DFFHOHUDWH  RSHUDWLRQV  DQG  LPSURYH  GH-          not only established consultation hotlines
    OLYHU\  TXDOLW\   DQG  DFWLYHO\  VWUHQJWKHQ  DFWLYH       DQG  PXOWLSOH  ZD\V  RI  GHFODULQJ   DQG  DOVR 
    and passive drug monitoring practices for                 continued organizing training courses and
    better risk management and control.                       educational publicity.
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    Implementation Strategy                                    early warning functions of ephedrine/
                                                               pseudoephedrine preparations were
    I. Improved Taiwan’s electronic                            added to the system to enable the health
       submission system                                       authorities to inquire data immediately.

        ,Q RUGHU WR LPSURYH WKH H൶FLHQF\ RI WKH           III. Reinforced the drug safety
    FRXQWU\¶V  GUXJ  LQVSHFWLRQ   GUXJ  DGPLQLVWUD-          surveillance and analysis
    WLRQ   DQG  GUXJ  UHYLHZ  RSHUDWLRQV   DQG  FRP-
    ply with the regulations of the International             TFDA continues to monitor and analyze
    Council for Harmonisation of Technical Re-            drug safety through the post-market adverse
    quirements for Pharmaceuticals for Human              GUXJ UHDFWLRQ UHSRUWLQJ V\VWHP  GRPHVWLF DQG 
    8VH  ,&+  DQG RWKHU LQWHUQDWLRQDO VWDQGDUGV           IRUHLJQ GUXJV VDIHW\ LQIRUPDWLRQ PRQLWRULQJ  
    TFDA continues to develop relevant elec-              and national drug safety related database.
    tronic common technical document guidance             ,Q  DGGLWLRQ   LQ  RUGHU  WR  VWUHQJWKHQ  WKH 
    and system function enhancements and the              practicability and convenience of the adverse
    digital integration of the electronic review          GUXJ  UHDFWLRQ  UHSRUWLQJ  V\VWHP   WKH  ,&+ 
    WDVN  IXUWKHU LPSURYLQJ WKH GUXJ UHJLVWUDWLRQ         ( %   5    DGYHUVH  GUXJ  UHDFWLRQ  QRWL¿FDWLRQ 
                                                          system was formally implemented starting
    II. Improvement of the trace and                      on September 2020.
       track system of drugs
                                                          $FKLHYHPHQWV DQG %HQH¿WV
    (I) TFDA continues selecting drugs to be
        included in “Trace and Track System               I. Reinforced the digitalization
        IRU  0HGLFLQDO  3URGXFWV ´  7)'$  KDV                management of Taiwan’s drug
        LQFOXGHG  EORRG  SUHSDUDWLRQV   YDFFLQHV             administration
        DQG  ERWXOLQXP  WR[LQ  SUHSDUDWLRQV   KLJK 
        concerned 50 items that are more likely              By integrating medical regulations and
        WR  EH  FRXQWHUIHLWHG   SVHXGRHSKHGULQH           LQIRUPDWLRQ PDQDJHPHQW  7)'$ KDV DGRSWHG 
        DQG  HSKHGULQH  SUHSDUDWLRQV  $GGLWLRQDOO\        a full online application approach for some
        Medicinal nitrous oxide was included on           application types starting July 2020. The
                                                          Guidance on Taiwan Electronic Common

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