[ad_1]
(Photo = provided smart image / material photo)
The government said that a total of 16 clinical trials are currently underway in Korea, including 15 corona treatments19 and 1 vaccine. 8 companies and 11 cases (9 countries) are conducting clinical trials abroad.
Among the companies, Celltrion said it has completed phase 1 clinical trials in 32 healthy adults and safety has been confirmed, for example no abnormal cases.
SK Bioscience is also conducting non-clinical trials for the development of a COVID-19 vaccine with the support of the Ministry of Health and Welfare and the Ministry of Science, Technology and Communication, and plans to apply for a phase 1 clinical trial early next month.
At the sixth meeting of the Pang Government Committee for the Treatment and Development of Corona 19 Vaccines, held on the 25th, the status of the development of treatments and vaccines by the main national companies was reviewed.
At this meeting, trade officials informed the pan-government support committee about difficulties in the clinical process, such as the difficulty of recruiting subjects due to the shortage of domestic patients, high uncertainty, high long-term costs and lack of clinical information abroad.
Since the clinical trial process is important to the rapid development of COVID-19 treatments and vaccines, the government decided to support clinical trial costs of approximately 94 billion won to ease the business burden.
The government selected eight projects last month as support targets, among which Celltrion will first determine the scale and conditions of support and conclude an agreement between the inter-ministerial drug development project group and the companies. Until the 12th of next month there will be a contest for the second project to support the cost of clinical trials.
(Photo = captured by the website of the Ministry of Food and Pharmaceutical Safety)
The government, in particular, is helping companies to operate the ‘National Center for Clinical Trials of Infectious Diseases’ seriously so that companies do not suffer in the process of recruiting subjects to participate in clinical trials and mutual recognition by of the Institutional Review Board (IRB).
The Ministry of Food and Drug Safety operates a ‘dedicated review team’ from the initial stage of development through clinical preparation and application for approval to minimize trial and error for companies and to rapidly review and approve clinical trials.
It also strengthens corporate clinical support abroad. For example, the Ministry of Science and ICT plans to provide relevant information using the global research and cooperation network owned by the Pasteur Institute and help connect local researchers and institutions.
If the drug and vaccine development is successful, this year it will invest 10 billion won to build the company’s production facilities and equipment so they can be produced without interruption. The government announced that it will support a total of 5.2 billion won by selecting two locations, including Binex and GC Green Cross, for the first time.
To support the development of COVID-19 treatments and vaccines, the government formulated a total budget of 260.4 billion won, an increase of 41.8 billion won from this year, and presented it to the National Assembly. .
