Page 20 - 2023 Taiwan Food and Drug Administration Annual Report
P. 20

2023 Taiwan Food and
Drug Administration

Annual Report

    Section 6                                            medicine, reinforce the mechanism of
                                                         drug shortage reporting, and ensure the
    Future Perspective                                   balance between supply and demand in the
                                                         healthcare system while at the same time
          With the discovery of novel substances         consolidating pharmacovigilance to ensure
    and the impact of newly emerging technologies        medication safety for the general public.
    and chemicals, the management of the hygiene     III. TFDA will continue to improve various
    and safety of food and medicinal products is          regulations under the “Medical Devices
    getting complicated each day. By integration          Act” and the “Cosmetic Hygiene and
    of different ministries and departments as well       Safety Act”; to enhance exchange and
    as the expansion of the business operators            collaboration with international laws
    and the participation of the public, TFDA             and regulations; and to build a modern
    is constructing a comprehensive protection            regulatory environment that is harmonized
    network for food, medicinal products,                 with international regulations. A
    and cosmetics safety. Future important                diversified and flexible review mechanism
    administrative plans include:                         for pre-market inspections will be in
    I. Strengthen the applicable intelligent              place and TFDA will provide dedicated
                                                          support to medical device businesses in
       technology and combine it in food and              terms of regulatory compliance as they
       drug safety and risk management and                develop innovative medical devices.
       continue to optimize the “Five-Point Food          The medical device digital clinical trial
       Safety” policy setting by integrating cross-       management platform will be launched
       ministerial and departmental resources,            and TFDA will continue to improve
       maximizing food safety management                  production source control, tracking
       resources, consolidating tracking and              management, and distribution practice, to
       follow-up, reinforcing border inspections,         accelerate the market approval of medical
       audits, and autonomous management among            device products so as to satisfy domestic
       business operators in order to enhance the         demands with better consumer protection.
       food management capacity in our country       IV. Implement the forward-looking “Food
       and to protect public health.                      Safety Construction Plan,” which
    II. Continue to complete the regulation               includes the “construction plan for a
                                                          modern food and drug national laboratory
        structure for regenerative medicinal              building coordinated with functional
        products, promote electronic management
        of drug administration, bridge smart

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