"Research Review Taking 2 Months Now 1 Week" Government Rolls Up Sleeves for Vaccine and Treatment Development

[Asia Economy Reporter Cho Hyun-ui] The government will establish priority criteria for clinical trial support and significantly reduce research review time through a shared Institutional Review Board (IRB) to expedite the development of treatments and vaccines for COVID-19.

The Pan-Governmental Support Group for COVID-19 Treatment and Vaccine Development held its first meeting on the morning of the 24th at the Government Seoul Office to discuss these plans. Recognizing that treatments and vaccines are essential hurdles to completely overcoming COVID-19, the support group will operate to facilitate continuous collaboration among industry, academia, research institutes, and hospitals, as well as to improve regulations and develop comprehensive government support measures.

Attending the meeting were Park Neung-hoo, Minister of Health and Welfare; Choi Ki-young, Minister of Science and ICT; Lee Eui-kyung, Commissioner of the Ministry of Food and Drug Safety; vice ministers from related ministries; and domestic experts in treatment and vaccine fields. The support group agreed to actively pursue policy support based on 28 suggestions collected from the field since the 17th, including information, technology and infrastructure sharing, institutional improvements, and R&D support, prioritizing two urgent institutional improvements.

First, priority criteria for clinical trial support will be established. Currently, demand for clinical trials of treatments and vaccines is surging, but there are limitations on available time and eligible patients for clinical trial support. Therefore, a strategic approach focusing support based on priority criteria is necessary. The support group will develop detailed judgment criteria for clinical trial support priorities based on fundamental principles such as patient safety, research ethics, public interest, and international standards.

Additionally, the shared Institutional Review Board (IRB) will expedite the review process for COVID-19-related research. Research involving clinical information or blood samples from patients and recovered individuals must undergo IRB review before initiation. However, when using an institution’s own IRB, review procedures have sometimes been lengthy or inconsistent regarding exemption decisions, causing inconvenience.

Accordingly, starting from the 29th, the support group will accept and promptly process COVID-19-related research requiring urgent public health measures, including national and local government direct or commissioned research, that qualify for IRB review exemption. Furthermore, a special review committee dedicated to COVID-19 research will be established next month to swiftly handle review procedures for studies not eligible for exemption. This will drastically reduce IRB waiting times from 1?2 months to within one week and provide exemption guidelines to enable other IRBs to conduct rapid exemption reviews.

At the meeting, the support group also decided to establish a pan-governmental blueprint (roadmap) covering strategies for domestic treatment, vaccine, and quarantine equipment development. The roadmap will include goals and schedules for domestic treatment and vaccine development, rapid regulatory support, production and national stockpiling of treatments and vaccines, localization goals and support plans for quarantine equipment, and expanded and expedited R&D investment. Drafts will be prepared by sector focusing on industry, academia, research, and hospitals, followed by expert review, with major decisions announced sequentially by early June.

Park Neung-hoo, Minister of Health and Welfare, stated, "As seen in recent exports of COVID-19 diagnostic kits, there is sufficient potential if companies, universities, research institutes, hospitals, and the government unite in the treatment and vaccine sectors." He added, "We will activate a continuous collaboration system centered on the support group for regulatory improvements and R&D."

Choi Ki-young, Minister of Science and ICT, said, "The Ministry of Science and ICT will prioritize discovering treatment candidate substances through drug repositioning strategies and also focus on vaccine development." He continued, "We will steadily advance the development of animal models for efficacy analysis to enable domestic companies and researchers to utilize them." He further added, "From basic research to understand the characteristics of the COVID-19 virus, to research infrastructure services sharing experimental facilities held by government-funded research institutes with companies, and operating the 'R&D Support Council' to resolve companies’ R&D difficulties, we will continue to dedicate ourselves to finding strategies and methods to respond to COVID-19 across the entire R&D spectrum."

This content was produced with the assistance of AI translation services.