South Korea

DCT Feasibility Assessment South Korea The below version control table serves to document all updates made to the guidebook. The purpose is to ensure the information is always accurate and up-to-date. Disclaimer...

This workbook provides an overview of the current and proposed regulatory landscape applicable in South Korea in relation to Decentralized Clinical Trials (“DCTs”). Clinical Trials are governed in Korea by the Ministry of Food and Drug Safety (M...

2.1 Name of Regulatory Authority Korea’s Ministry of Food and Drug Safety (MFDS), formerly known as the Korea Food & Drug Administration (KFDA), is the main regulatory body for drugs, medical devices, food, and cosmetic products, that overs...

3.1 Provide a list of documents needed to be submitted for EC/IRB review and approval including the number of copies and/or translations as relevant.  The IRB/IEC should be provided with the following documents (one copy of each document t...

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 in...

5.1 Does the local regulation require PI/CI to be approved/registered by any regulatory authority (e.g., RA/EC)?   The Korean GCP Guidelines state that Korean PIs must be well educated, trained, and have foreign language abilities. It is a...

6.1 Provide a list of documents needed for export permit relevant to biological specimen shipment.  See Section 2.7 of this guidebook. 6.2 Does local regulation require any separate consent for biological specimen collection, storage...

7.1 Do the country regulations allow Decentralized Clinical Trials (DCT) elements (e.g., eConsent, ePRO administration, remote investigator site, etc.)? Yes . There are currently no regulations preventing the conduct of DCTs in Korea.  7...

8.1 What data privacy and/or technology regulations need to be complied with to run a trial in the countries of interest?   Data protection is governed in Korea by the Personal Information Protection Act (General Law) as well as the Act on...

9.1 Clinical trial subject recruitment: Are digital advertisements (including social media streams such as TikTok) allowed and, if so, what regulations govern them ? There are no specific guidelines on this matter. Marketing materials are the ...

10.1 Clinical Trial with Investigational Medicinal Product 10.2 Pediatric Investigation Plan (PIP) There is no requirement for a Pediatric Investigation Plan in South Korea. Plans for the investigation of a product in the pediatric ...

Ministry of Food and Drug Safety (MFDS) Our Works , MFDS, accessed December 2022 Global Regulatory Partners Inc (February 2022) Clinical Trial Application (CTA) in South Korea ,  Global Regulatory Partners, accessed December 2022 Bio...

None.