Page 54 - 2023 Taiwan Food and Drug Administration Annual Report
P. 54

2023 Taiwan Food and
Drug Administration

Annual Report

    for their reference and adoption to boost the           Given the quick global economic and
    test capacity and international publicity of      trade developments and restructuring of the
    our country and to facilitate the exchange        supply chain, the Ministry of Health and
    of information on medicinal products              Welfare implemented the “Mid-to-Long-
    internationally. In addition, while the quality   term Plan for New Southbound Medicial
    control model for emerging biotech medicinal      Health Collaboration and Industrial Chain
    products such as nucleic acid drugs is yet to be  Development” to go with the new southbound
    standardized internationally, TFDA has already    policy of our country. With the implementation
    defined the novel NGS test technology to lead     of the Plan, TFDA hopes to strengthen
    the innovative test capacity of our country       collaboration with new southbound countries
    in medicinal products. Such technology has        in medicine applying our experience from the
    been applied in the testing of 49 batches         long-term devotion to the establishment of an
    of COVID-19 vaccines, with accumulated            international management setting for laws and
    capabilities in monitoring the quality and        regulations on medicine and our strengths in
    coping with the quality risk of emerging          the industry. Stage 2 (2022-2025) is planned
    biotech medicinal products.                       to stabilize partnerships with new southbound
                                                      countries and to advance into the international
    Section 6                                         market for the medicinal industry by
                                                      investigating the supervision and management
    Investigate and                                   strategies and regulatory updates for medicinal
    Analyze Information                               products in new southbound countries.
    on Laws and
    Regulations                                       ▍	Implementation Strategy
    Governing Medicinal
    Products in New                                   I. Collection and analysis
    South-bound                                         of regulatory information
    Countries                                           on laws and regulations
                                                        governing medicinal
    ▍	Introduction of the Policy                        products in new southbound
                                                        countries and strategies
                                                        adopted by advanced
                                                        countries in entering the new

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