[Press Release, March 27, 2020 / unofficial translation ]


The Ministry of Food and Drug Safety Provides Support for COVID-19 Treatment/Vaccine Development and Stable Management of Drug Supply
> Priority/quick review of clinical trial plans for the development of COVID-19 treatments
> Management of drug supplies for COVID-19 treatments, such as through special import


□ The Ministry of Food and Drug Safety (Minister Lee Eui-Kyung) has been supporting the quick development of COVID-19 treatments/vaccines and ensuring the stable supply of drugs used to treat COVID-19.

[1] Support for COVID-19 Treatment/Vaccine Development
- Support for Commercialization, including development consultation
- Priority/quick reviews on clinical trial plans

[2] Government-wide cooperation on COVID-19 Treatment Development Project

[3] Stable Supply Control of COVID-19 treatments
- Special import for drugs without domestic approval
- Monitor supply status of drug manufacturers/importers

* Clinical trial: A test performed on human subjects which confirms the efficacy of a drug and checks for any adverse reactions to prove the drug is safe and effective.


≪Support for COVID-19 Treatment/Vaccine Development≫

□ The MFDS has constructed a commercialization team (Feb. 3) within the Headquarters for COVID-19 emergency response support and is providing support for commercialization by operating a separate consultation window※ for pharmaceutical companies planning to develop COVID-19 treatments/vaccines while also performing priority/quick reviews on clinical trial plans.
※ You can make inquiries by calling the “commercialization team” (043-719-2912) or can make a reservation through the “integrated consultation reservation” system on the MFDS website.

○ As of the present, a total of 11 applications have been submitted for COVID-19-related clinical trials, and after consultations with experts from the Korean Society of Infectious Diseases, the Korean Society for Antimicrobial Therapy, and other organizations, 5 among them have been approved. (As of Mar. 26)



▶ 3 clinical trials (Mar. 2, Mar. 5) regarding “Remdesivir” (Ebola treatment)
▶ 1 clinical trial (Mar. 20) regarding “Kaletra tablets” (HIV-1 infection treatment) and “hydroxychloroquine tablets” (malaria treatment)
▶ 1 clinical trial (Mar. 25) regarding “hydroxychloroquine tablets’ (malaria treatment)

○Furthermore, the MFDS granted approval for 6 clinical trials to allow drugs currently under clinical trials as influenza treatments to be used for COVID-19 treatment, and 10 more such approvals are being reviewed. (As of Mar. 26)
※ Approval for use in treatment purposes: A system allowing investigational drug which have not yet received approval as pharmaceutical products to be used, after receiving special approval from the MFDS, for the purpose of treating emergency patients whose lives are at risk or for whom there are no alternative means of treatment, etc.

○ Furthermore, we have prepared a “guidance for COVID-19-related clinical trials” and have shared it with the Korean Association of Institutional Review Boards (KAIRB), etc., so that approved clinical trials can be carried out swiftly.
* Main content: : ① Priority reviews of COVID-19-related clinical trials at institutional review board (IRB) ② Review carried out using non-face-to-face methods, such as videoconferencing ③ Allowing consent to be given by clinical trial subjects through explanation over the phone, in consideration of quarantine measures, etc.


≪Governmental COVID-19 Treatment/Vaccine Development Project Cooperation≫

□ The MFDS is contributing to the COVID-19 treatment development projects promoted by the Ministry of Science and ICT and Korea Centers for Disease Control and Prevention and is thereby providing support to accelerate such development as much as possible.

○ We plan to share information related to clinical trials from the early stages of development and review scientific feasibility, thereby providing support to eliminate trial-and-error

▶ Ministry of Science and ICT: Implementing a Drug Re-purposing Project to discover drugs approved by the USA’s FDA which are effective at treating COVID-19 then deliver research results to the medical community and enable them to be used clinically
▶ Korea Centers for Disease Control and Prevention: Expand the scope of use of existing medications for the development of COVID-19 treatment, launch clinical trial research projects related to antibody treatments/plasma treatments/vaccines


≪Managing Supply of Drugs Used to Treat COVID-19≫

□ Special import of drugs which are not approved domestically is being carried out when the Korea Centers for Disease Control and Prevention requests it for the sake of treating COVID-19.

○ Accordingly, the 3 cases of special import have been allowed for “Kaletra solution,” an HIV-1 infection treatment which has not been approved for use in Korea.
※ Special import: A system allowing drugs which have not received an item approval to be imported in cases where the head of a related governmental department makes such a request for preparing for an infectious disease pandemic, etc. (Item approval is normally required to import a medication)


□ Furthermore, the status of the domestic supply of “Kaletra” and “hydroxychloroquine tablets,” etc. being used to treat COVID-19* is being monitored, to thereby ensure we are prepared to import or produce these drugs if needed.
* Based on expert recommendation regarding drug treatments for COVID-19 (Mar. 13 2020, The Korean Society of Infectious Diseases, etc.)

○ Currently, businesses in Korea have secured “Kaletra tablets” enough for around 15 thousand people and “hydroxychloroquine tablets” enough for 200 thousand people (as of Mar. 26).


□ The MFDS pledges to provide continuous support to help COVID-19 treatments/vaccines be developed quickly and closely cooperate with related governmental departments such as the Korea Centers for Disease Control and Prevention to stably control the supply of drugs used to treat COVID-19, making sure a sufficient supply is given to the medical sites that need them.