2. General Questions
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2. General Questions
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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 oversees clinical trials in South Korea.
https://www.mfds.go.kr/eng/index.do
2.2 Name of Ethics Committee
According to South Korea’s Bioethics and Safety Act, the establishment of an institutional review board (IRB), as a self-regulatory system, is a requirement for all institutions performing human research and handling human-derived specimens.
2.3 Clinical Trial Application Language
Korean.
2.4 Is regulatory approval required from both health authorities and/or EC?
Yes, regulatory approval is required from both MFDS and the institution’s IRB.
2.5 Can regulatory authority and EC submissions be done in parallel?
Yes, the Clinical Trial Authorization (CTA) process allows for applications to be submitted in parallel to the Ministry of Food and Drug Safety (MFDS) and institutional review boards (IRBs)/Ethics Committees (ECs).
2.6 Requirement of any import permit/license before investigational product/study product is shipped from point of origin
Yes, an import permit is required before shipping investigational products to South Korea. The import permit is obtained from the Korea Pharmaceutical Traders Association (KPTA) following approval of the clinical trial application. The KPTA is a non-profit organization authorized by the MFDS to issue entry permits for imported pharmaceuticals, cosmetics, and herbal medicines. The process uses the Electronic Data Interchange of the Korean Customs Service.
2.7 Biological Specimen Export Requirements
The movement of biological samples is regulated by the Korean Customs Service. Sponsors should confirm if their samples are subject to customs clearance prior to shipment.
2.8 Are studies of GMOs permitted (e.g., GMOs used in vaccines/vaccine manufacture and other modified products)?
Yes, studies of GMOs are permitted.
GMOs are regulated by MFDS as any other type of drug. A specific guideline exists for gene editing of ATMPs.
Under the Regulation on Permission, Notification and Examination of Drugs, when filing an application for permission or submitting a drug master file (DMF) for any injectable drugs containing animal-derived ingredients (such as sodium hyaluronate extracted from rooster combs), the origin animal of the animal-derived ingredients and the part of the animal from which the ingredients were extracted must be specified.
For drugs containing ruminant-derived substances, the selection of ingredients (the country of origin of the ruminant, the age of the ruminant) or the relevant processing methods must be described in the documents to prevent infection of transmissible spongiform encephalopathy (TSE).
Any person with permission to or who has imported a drug containing animal-derived substances (including additives) must print, on the bottle or packaging of the drug, the name of the substances, the origin animal, and the part of the animal from which the substances are extracted. Any drugs without these indications cannot be sold, stored, or displayed for sale purposes. Violation of these rules can result in criminal liability.
2.9 Is in-country sponsor presence/representation required?
Yes. To obtain approval of a clinical trial protocol in South Korea, a foreign company without an established presence in Korea must delegate all rights and responsibilities for the execution of the clinical trial through an agreement with a contract research organization (CRO) established in Korea.
2.10 Is there any mandatory requirement to identify a local PI or can a PI be based in a foreign country?
Yes, the PI must be a locally licensed physician.
South Korea operates in line with the ICH GCP requirements which define the Principal Investigator as the person responsible for the conduct of the clinical trial at a trial site.
2.11 Is there any mandatory requirement to identify a local chief or coordinating investigator?
No, if the study is a multicentre trial, a local coordinating investigator may be selected but this is not mandatory. The coordinating investigator is to be selected by the sponsor.
2.12 If the applicant is CRO or a third party, does regulatory authority need any authorization or transfer of obligations from the sponsor? Does the authorization letter need to be notarized and/or apostilled?
Yes, if a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.
To obtain approval for a clinical trial protocol in South Korea, a foreign company without an established presence in Korea must delegate all rights and responsibilities for the execution of the clinical trial through an agreement with a contract research organization (CRO) established in Korea.
https://credevo.com/articles/2017/09/25/south-korea-clinical-trials-regulatory-process/
A sponsor may transfer any or all of the sponsor's trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO shall implement quality assurance and quality control.
Any trial-related duty and function that is transferred to and assumed by a CRO shall be specified in writing. There is no specific template for the transfer of obligations.
Any trial-related duties and functions not specifically transferred to and assumed by a CRO are retained by the sponsor.
2.13 Is there a requirement to register clinical trials on a local registry or database?
Yes, sponsors should register their approved clinical trial with the Clinical Research Information Services (CRIS).
2.14 What is the local requirement for clinical study documents archival; minimum of years for the archival, specific format followed (electronic/paper and/or both)?
The sponsor, or other owners of the data, shall retain all of the sponsor-specific essential documents pertaining to the trial for five years after the completion of the trial. The sponsor shall retain all sponsor-specific essential documents in conformance with the applicable regulatory requirement(s) of the country(ies) where the product is approved, and/or where the sponsor intends to apply for approval(s).
If the sponsor discontinues the clinical development of an investigational product (i.e. for any or all indications, routes of administration, or dosage forms), the sponsor shall maintain all sponsor-specific essential documents for at least 5 years after formal discontinuation or in conformance with the applicable regulatory requirement(s).
The sponsor shall inform the investigator(s)/institution(s) in writing of the need for record retention and shall notify the investigator(s)/institution(s) in writing when the trial-related records are no longer needed.
2.15 Requirements around periodic safety reporting and timelines on SAEs/AEs/ADRs/SUSARs/DSURs.
The sponsor must report deaths and any life-threatening SUSAR to the Ministry of Food and Drug Safety ("MFDS") within 7 days. All other SUSARs are reported within 15 days.
Per Article 13 of the Korean Good Clinical Practices, if the sponsor is a foreign entity, the investigator in charge is to do the reporting to MFDS. Per the Korean Good Clinical Practices, investigators are to report all serious and unexpected adverse drug reactions to the Ethics Committee and MFDS within 7 days for fatal or life-threatening events and within 15 days for all others.
Adverse events can be reported to MDFS through the Korea Adverse Event Reporting System (KAERS).
All serious adverse events (SAEs) shall be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports shall be followed promptly by detailed, written reports. The immediate and follow-up reports shall identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses. The investigator shall also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the Commissioner of Korea Food and Drug Administration and the IRB/IEC.
Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.
The sponsor shall expedite the reporting to all concerned investigator(s)/institutions(s), to the IRB(s)/IEC(s), where required, and to the Commissioner of Korea Food and Drug Administration of all adverse drug reactions (ADRs) that are both serious and unexpected:
- Within 7 days when the sponsor is informed of the fact that ADRs could cause death or threaten the subject's life. In this case, the sponsor shall make an additional report within 8 days from the initial reporting date.
- Within 15 days when the sponsor is informed of all other both serious and unexpected ADRs.
Such expedited reports shall comply with the applicable regulatory requirement(s) and with the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting.
The sponsor shall submit to the regulatory authority(ies) all safety updates and periodic reports, as required by applicable regulatory requirement(s).
2.16 Requirement on any periodic clinical study update, specific template, and its frequency (e.g., interim, or annual progress report and final report, etc.)?
The investigator shall submit written summaries of the trial status to the IRB/IEC annually, or more frequently if requested by the IRB/IEC.
The investigator shall promptly provide written reports to the sponsor, the IRB/IEC, and, where applicable, the institution on any changes significantly affecting the conduct of the trial, and/or increasing the risk to subjects.
For reported deaths, the investigator shall supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).
Upon completion of the trial, the investigator, where applicable, shall inform the institution; the investigator/institution shall provide the IRB/IEC with a summary of the trial’s outcome, and the regulatory authority(ies) with any reports required.
2.17 Does the local regulation require notification of “serious breaches” of GCP or the trial protocol?
Yes, MFDS must be notified of any serious breaches of GCP.
2.18 Does RA/CA require insurance and indemnity to cover the sponsor and investigator’s potential liability?
Yes, according to Article 32 of the Korean GCP Guidelines, the sponsor shall provide insurance or indemnify the investigator/institution against claims arising from a trial.
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