Advanced medical technology
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 70 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 464 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 level-3 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:
- Monoclonal antibodies screened during the SARS outbreak were used to develop a rapid test that can be completed in about 15 minutes, and the technology has been transferred to domestic manufacturers and has obtained the Emergency Use Authorization (EUA) from the Taiwan Food and Drug Administration (TFDA).
- The results for the rapid screening test using synthetic and monoclonal antibodies with specificity are available in about 15 minutes.The technology has been transferred to domestic manufacturers and has obtained the Emergency Use Authorization (EUA) from the TFDA. In addition, by using computational tools to design synthetic antibody libraries to be selectedscreened with phage display system for novel antibodies useful in biomedical applications, a phage-displayed GH (Generic Human) synthetic antibody libraries designedconstructed with enabling approaches, leading to the throughput capacities to uplift the innovativenessproductivity in developing antibody therapeuticsdiagnostics.
- The mini version portable PCR, iPMx Molecular Rapid Test System, can produce results in about 60 minutes, and in the international COVID-19 Proficiency Test held by QCMD (Quality Control for Molecular Diagnostics), iPMx demonstrated compatible performance with international brands by yielding correct results for all samples. The technology has obtained the Emergency Use Authorization (EUA) from the TFDA , Japan PMDA and EU CE-IVD approval for the sale and manufacture of this system.
(II) Pharmaceutical products:
- To meet the urgent need for drugs during the pandemic, we are practicing rapid drug synthesis (following the example of completing the Remdesivir synthesis exercise in 14 days) to ensure production efficiency and quality, and to strengthen drug production and supply chain stability.
- By utilizing artificial intelligence technology, new drug development strategies can be actively explored, and the efficiency and safety of drug research and development can be improved. This technology can also aid in identifying new therapeutic targets and drug combinations, and in promoting the development of new strategies for old drugs.
- Subsequently synthesized Favipiravir and conducted a clinical trial on HCQ.
- TFDA has approved the import of Remdesivir, Molnupiravir, Paxlovid and Evusheld COVID-19 Drugs on June 2, 2020, January 13, 2020, January 17, 2022 and August 22, 2022 as a special case emergency use authorization according to the Article 48-2 of the Pharmaceutical Affairs Act.
- Utilized four technological platforms for the development of vaccines, including peptide vaccine, DNA vaccine, recombinant vaccine, and subunit vaccine. Ultimately, the DNA vaccine was selected as the main focus for the development of a new virus vaccine. Currently, an application for new drug clinical trials (NID) is being submitted. Additionally, NHRI has also begun to establish an mRNA technology platform, which can be applied in vaccine development in the future.
- Pioneered a T cell-based nano vaccine for COVID-19, which has been proven to have strong and broad protective effects in mouse immunization tests. The formulation is currently undergoing animal studies against additional COVID-19 strains with international collaborators at University of Texas, Medical Branch. Virus-like particles (VLP) and viral vectors were used to produce candidate vaccines, and a lab mouse immune response experiment will be carried out. In addition, a broadly protective mRNA vaccine of SARS-CoV-2 has also been developed, and the technology has been transferred to a domestic manufacturer.
- 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. After recruitment, TFDA completed the destruction of paper and electronic data of platform on 7 June 2021.
- TFDA has approved the import and manufacture of AstraZeneca, Moderna, Medigen, Pfizer-BioNTech, Novavax, Moderna bivalent (OriginalOmicron BA.1) and Moderna bivalent (OriginalOmicron BA.4/5) COVID-19 Vaccine on February 20, 2021, April 22, 2021, July 30, 2021, August 3, 2021, June 22, 2022, September 2, 2022 and October 26, 2022 as a special case emergency use authorization according to the Article 48-2 of the Pharmaceutical Affairs Act.
- Till April 27, 2023, TFDA has completed the vaccine testing and issued batch release certificate for 46 batches of AstraZeneca COVID-19 vaccine (16,022,750 doses),44 batches of Moderna COVID-19 vaccine (29,820,850 doses), 26 batches of BioNTech COVID-19 vaccine (22,857,486 doses), 3 batches of Novavax COVID-19 vaccine (1,306,200 doses) and 45 batches of MVC COVID-19 vaccine (5,664,743 doses).
- 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).
- Last Updated:2023-05-12
- Data Source:Food and Drug Administration, Ministry of Health and Welfare
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