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I. Established a green channel for rapid review with guidance from designated personnel:

(I) Formed a project team to fully support the development of test kits required for domestic disease prevention.
(II)Established laws on the green channel and formulated 3 performance  verification reference documents and 2 explanatory documents, actively provided guidance to major R&D projects in Taiwan, and accelerated the domestic test kit time to market, such that there are currently more than 60 domestic test kit products being marketed.

II. Successfully fostering the development of domestically produced test kits:

(I) The government provided guidance to companies in completing pre-clinical testing and clinical evaluation, and accelerated review (on average each case requires 7 work days to process).
(II) One domestically produced test kit has completed clinical evaluations and is now available on the market. It takes 85 minutes from sample collection to output results, sensitivity and specificity both exceed 95%, and special case manufacture was approved.
(III) In order to respond to the public health event of global SARS-CoV-2 epidemic, and testing requirements, Taiwan Food and Drug Administration (TFDA) made the SARS-CoV-2 reference standards and respiratory relevant virus panels. These standards and panels got certification of Symbol of National Quality (SNQ) awards in 2020, and 398 vials were supplied to national producers or related research agencies for products’efficacy evaluation, which successfully assisted 7 domestic institutes to acquire the emergency use of authorization (EUA) of their products.

III. Established a technical support platform of COVID-19 to accelerate the development of vaccines, drugs and rapid test kits:

(I) The platform established the specimens application mechanism through integrating the domestic biosafety three-level laboratories and providing related virus assays.
(II) Taiwan collected specimen and clinical data from COVID-19 patients for value-added analysis and providing to industry, academia, research institutes, and the medical community through the Taiwan COVID-19 Research Network and Database Project and National Biobank Consortium of Taiwan to accelerate overall research for disease prevention.
(III) TFDA established and publicized of analytical methods, including “SARS-CoV-2 live virus neutralization assay for evaluation potency of COVID-19 vaccines” and “Immunogenicity determination of COVID-19 vaccines”, to accelerate the developments of quality control assays for domestic COVID-19 vaccines. Additionally, TFDA simultaneously established the national standard of serum for SARS-CoV-2, providing to act as the reference controls for evaluation of immunogenicity of COVID-19 vaccines.

IV. Collecting resources and cutting-edge technologies for the development of rapid test kits, therapeutics, and vaccine:

(I) Rapid test kits:
  1. Monoclonal antibodies screened during the SARS outbreak were used to develop a rapid test that can be completed in about 15 minutes, and technology transfer procedures to a domestic manufacturer have begun.
  2. The results for the rapid screening test using synthetic and monoclonal antibodies with specificity are available in about 15 minutes.
  3. The mini version portable PCR can produce results in about 60 minutes, and has the potential of becoming the world's first handheld nucleic acid rapid screening test system.
(II) Pharmaceutical products:
  1. Worked on rehearsal of small scale of synthesis procedure of Remdesivir effectively in 14 days.
  2. Actively used AI screening strategy to identify marketed drugs and screening of new compounds for Covid-19 disease, to accelerate the development of drugs.
  3. Subsequently synthesized Favipiravir and conducted a clinical trial on HCQ.
  4. TFDA has approved the import of Remdesivir, Molnupiravir and Paxlovid COVID-19 Drugs on June 2, 2020, January 13 and January 17, 2022 as a special case emergency use anthorizutior according to the Article 48-2 of the Pharmaceutical Affairs Act.
(III) Vaccine:
  1. Used 4 technology platforms for development, including peptide vaccine, DNA vaccine, recombinant vaccine, and subunit vaccine; clinical trials are expected to begin at the end of 2020.
  2. Developed a nano vaccine that imitates coronavirus and animal trials are currently being carried out. Also, Virus-like particles (VLP) and viral vectors were used to produce candidate vaccines, and a lab mouse immune response experiment will be carried out.
  3. Central Epidemic Command Center announces to establish a “Platform for the Registration of Intention to Participate in Clinical Trials of COVID-19 Vaccines”. As is needed to prevent against novel coronavirus, to expedite clinical trials of vaccines, and to support domestic research and development of vaccines against COVID-19, a platform is created for the person who is willing to take part in clinical trials of COVID-19 vaccines.
  4. TFDA has approved the import and manufacture of AstraZeneca, Moderna, Medigen and Pfizer-BioNTech COVID-19 Vaccine on February 20, April 22, July 30 and August 3, 2021 as a special case emergency use anthorizutior according to the Article 48-2 of the Pharmaceutical Affairs Act.
  5. Till May 18, 2022, TFDA has completed the vaccine testing and issued batch release certificate for 46 batches of AstraZeneca COVID-19 vaccine (16,022,750 doses), 26 batches of Moderna COVID-19 vaccine (19,177,300 doses), 19 batches of BioNTech COVID-19 vaccine (17,832,324 doses), and 45 batches of MVC COVID-19 vaccine (5,664,743 doses).
  6. For information about the batch release of the COVID-19 vaccine, please visit the official website of the TFDA (URL: http://www.fda.gov.tw/TC/download .aspx?cid=114).

  • Created:2020-05-14
  • Last Updated:2022-05-31
  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Count Views:0
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