Ministry of food and drug safety

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[Press Release, April 13, 2020] MFDS Provides Strategic Support for COVID-19 Treatment and Vaccine Development
  • Registration Date 2020-06-17
  • Hit 317
[Press Release, April 21, 2020 / unofficial translation]

MFDS Provides Strategic Support for COVID-19 Treatment and Vaccine Development
- Operating “Intensive and Rapid Commercialization Support Program” (GO Expedited Review Program) -

□ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) is preparing/operating the “Intensive and Rapid Commercialization Support Program” (GO Expedited Review Program) to expand treatment opportunities for the public through swift COVID-19 treatment and vaccine development.

○ This program was designed to spur COVID-19 treatment and vaccine development and thereby help citizens return to normal lives while simultaneously securing national competitiveness in the midst of fierce competition on the development and production of treatments and vaccines around the world.

□ The main goal of the “GO Expedited Review Program” is to reduce development time by minimizing trial-and-error at each stage while also securing effectiveness and safety of the product with outstanding support strategy regarding research and development/clinical trial approval/approval and review/information sharing/international cooperation.

[ GO Expedited Review Program ]
. Research Support: sharing scientific advice and resource in development stage
. Approval/Review Support: professional consulting by highly experienced reviewers in approval/review, exemptions from submitting documents/Expedited review for clinical trial approval and product approval
. Technical Information Support: providing information related to clinical trial approval status and approval/review
. Cooperation Support: strengthening cooperation with foreign regulatory authorities and installing hot-line to resolve problems during product development

≪Research Support≫
○ The MFDS will provide scientific consulting to help determine substances that can be commercialized when government/government-funded research centers are searching for candidate substances; develop and share animal models infected with COVID-19 virus for developers to use them during product efficacy evaluation; and support the development of protocols for clinical use of treatments and vaccines

≪Support for Approval/Review≫
○ The MFDS will open “COVID-19-exclusive Consultation Window” covering all stages from R&D to approval/review, designate a Project Manager to provide customized support for each stage of development for products with therapeutic potential.

○ For drugs with potential therapeutic or preventive effects against COVID-19, the MFDS is planning to provide help for developers start conducting clinical trials by reducing the mandatory document submission required at the development stages to a minimum. For example, toxicity test would be exempted for vaccines developed on a platform proven to be safe.

○ Furthermore, the MFDS plans to operate an review team composed of experienced reviewers to drastically reduce clinical trial review period to 7 days or less for substances that have been used or 15 days or less for new substances; and also prioritize the issuance of approval for such products.

≪Technical Information Support≫
○ The MFDS plans to provide information such as a “Checklist for COVID-19 Treatment Development” containing clinical trial planning methods and FAQs and answers related to clinical trials, and also quickly release the approval status of clinical trials on treatments and vaccines

≪Domestic and Overseas Cooperation Support≫
○ The Ministry plans to install and operate a hot-line connected with the “head of commercialization support team” to immediately address problems and questions that arise during product development processes and share information on clinical trials and reviews performed in different countries through international cooperation such as the ICMRA.*
* ICMRA (International Coalition of Medicines Regulatory Authorities)

□ The MFDS will make its utmost efforts to ensure prompt development of safe and effective treatments and vaccines by cooperating with related government organizations and the industry, academia, research centers, and hospitals on the front line of product development to .
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  • 4.13 Supporting Development of VACCINE.pdf Download

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