Page 159 - 2023 Taiwan Food and Drug Administration Annual Report
P. 159

7Appendix

Serial  Name of the                    URL                          Brief Introduction                 QR Code

number Website in English

                                                     This system provides online submission for

                                                     drug registration, post-approval changes, and

        E Platform for Drug    https://e-sub.fda. license renewal. Reviewers and applicants can

17 Review and Submission gov.tw/dohclient/ both access this platform to review and check

        (ExPress)              Login.aspx            the progress of the application cases, so as to

                                                     control the review timeline and enhance review

                                                     efficiency.

18      Trace and track system https://dtracebook.   A system that offers businesses to upload the
        of medicinal products fda.gov.tw/            tracking and tracing information of medicinal
                                                     products electronically.

                                                     The system allows pharmaceutical dealers

                                                     and healthcare facilities to report shortages in

                                                     the supply of medicinal products in the nation

19      Drug Supply            https://dsms.fda.     and real-time evaluations and management
                                                     in order to prevent against possible impacts
        Management System gov.tw

                                                     that may result of insufficient supply of

                                                     medicinal products to ensure people’s right to

                                                     medication.

20      National Adverse Drug  https://adr.fda.gov.  The general public, medical professionals, and
        Reaction Reporting     tw                    manufacturers can use this system to report
        System                                       adverse drug reaction

                                                     The institutions, business operators, and
                                                     related professionals with controlled drug
        Controlled Drugs       Https://cdmis.fda. registration certificates can apply for pre-
21      Management             gov.tw                market controlled drugs via the system,
        Information System
                                                     to effectively enhance administrative
                                                     efficiency and service quality.

22      Drug Abuse             Https://dars.fda.     The system allows healthcare facilities
        Reporting System       gov.tw                to promptly report any cases of drug
                                                     abuse, in order to assess the trends of
                                                     drug abuse and instantly understand the
                                                     current status of drug abuse in Taiwan.

        Urine Test for Drug                          A system for the regular inspection in urine
        Abuse Reporting        Https://udars.fda. or narcotics test results of drug abuse
23      System                 gov.tw                cases by relevant domestic inspection

                                                     institutions.

        Searching System
        of Approved            https://adms.fda.
        Advertisement for gov.tw/adms/               A system allowing the public to inquire
24      Drugs and Medical PUBLIC/PQuery.             information on approved advertisements
                                                     for medical products, and medical devices.
        Devices Management asp
        System

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