4. Regulatory Authority (RA)/Competent Authority (CA)
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4. Regulatory Authority (RA)/Competent Authority (CA)
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4.1 Provide a list of documents needed to be submitted for RA/CA review and approval including the number of copies and/or translations as relevant.
The content of the CTA is shown in the table below. All documents should be translated into Korean. CTA can be submitted electronically through the Electronic Filing System (nedrug).
4.2 Time required for RA/CA review and approval process and turnaround time if any query is raised during the review process.
The MFDS review time is typically 30 days. Where additional information is requested from the Sponsor, the review clock will stop.
4.3 Does the regulation support electronic submission?
Yes, all applications must be submitted online.
https://nedrug.mfds.go.kr/index
4.4 Does the regulation require the applicant to be a Principal Investigator (PI)/Chief Investigator (CI)?
The applicant needs to be a local Korean organization. This does not need to be the PI.
4.5 Please describe the process of RA/CA submission for clinical trial approval.
The documents required as part of the application are shown in the table below. All documents should be translated into Korean. The application can be submitted electronically through the Electronic Filing System (nedrug).
After receiving the CTA, MFDS reviews it within 30 days following the process shown in the below figure.
Before starting the conduct of clinical trials in South Korea, sponsors should receive MFDS and IRB approvals. Additionally, they have to register their approved clinical trial with the CRIS (Clinical Research Information Services), which is an online registration system for clinical trials in South Korea.
4.6 Does the RA/CA provide written acknowledgment of the submitted application? If not, describe how the application is tracked.
Yes, MFDS will confirm receipt of the application in the electronic system.
The MFDS will inform the applicant of the progress of approval after their internal meeting which will include a 30-day period where the applicant can correct deficient information.
4.7 What is the relevant RA/CA fee in local currency/USD? Please provide as much information as possible (e.g. if the fee is different for notification/approval, initial submission, amendment, study with IMPD and study without IMPD, etc.)
4.8 Does RA/CA accept checks or payment can be made electronically? Please provide details on (1) A/C number; (2) A/C Name; (3) Sort Code; (4) Swift Code; (5) Bank address, etc. Where can remittance advice notices be sent?
Payments are made electronically.
4.9 Is there any guidance tool available for making electronic applications? If yes, provide the link and/or step-by-step instructions.
There is no specific guidance available.
4.10 Does RA/CA require any screenshots/mock screens for participant-facing materials?
Yes, where patient-facing materials are electronic, screenshots should be provided.
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