Advanced medical technology- Crucial Policy for Combating COVID-19 press enter to main content
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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 40 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. 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.

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.
(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.The Taiwan Food and Drug Administration (TFDA) has approved the import of AZ and Moderna COVID-19 Vaccine on February 20 and April 22, 2021 as a special case according to the Article 48-2 of the Pharmaceutical Affairs Act.
5.On March 17, the Central Epidemic Command Center (CECC) said that the Taiwan Food and Drug Administration (TFDA) had completed the vaccine inspections and issued the batch release certificate for the first batch of AstraZeneca COVID-19 vaccine, 116,500 doses, imported from South Korea, and was released on March 18.
6.The TFDA had completed the vaccine inspections and issued the first two batches release certificate of Moderna COVID-19 vaccine (148,800 doses) on the 7th June 2021.
7.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:2021-06-18
  • Data Source:Food and Drug Administration, Ministry of Health and Welfare
  • Count Views:0
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