Taiwan Food and Drug Administration approves Remdesivir to treat patients with severe COVID-19 disease

  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Created:2020-06-11
  • Last Updated:2020-06-11

    In order to protect the right to receive treatment for critically ill patients, and take precautions against the possible development of COVID-19 in the future, Taiwan Food and Drug Administration (TFDA) of the Ministry of Health and Welfare (MOHW) hold a meeting on May 29, 2020 and invited pharmaceutical and clinical experts to discuss the application and approval requirements of Remdesivir.

    Given that the efficacy and safety of Remdesivir supported by preliminary evidence, the drug has been approved by other health authorities internationally. Taking into account of domestic public health needs and the medical benefit as well as the risk assessments, the participating experts suggested TFDA consider conditional approval of Remdesivir for patients with severe SARS-CoV-2 infection, according to the Article 48-2 of Pharmaceutical Affairs Act, provided that the pharmaceutical company would implement a risk management plan (RMP) to ensure the safety after the importation.