South Korea Clinical Trial Industry at a Glance
South Korea has secured the 4th position globally in 2023 for the number of clinical trials conducted with Seoul continuing to be one the top cities in the world for industry-sponsored trials. In addition, there has been a notable increase in Phase I multinational clinical trials in South Korea, ranking it in the 7th place with 3.92% of market share in 2023, making it a highly preferred destination for clinical trial conduct in Asia and globally.
Implementation of the Investigational New Drug Application in South Korea
The Investigational New Drug (IND) Application was introduced to Korea on December 3, 2002 with the enactment of the Guideline on IND application by the Ministry of Food and Drug Safety (MFDS), formerly the Korea Food and Drug Administration (KFDA). In 2022, the Korean Ministry of Food and Drug Safety (MFDS) approved a total of 711 IND applications. Of these, 49% were global, 35.3% were locally initiated and 16% were investigator-initiated trials. Oncology was the leading field with 259 INDs approved, and the number of early phase studies (Phase I-II) initiated were nearly double that of Phase III.1
Previously, the IND was only a part of New Drug Application (NDA). Therefore documentation on manufacturing and quality control facilities, authorised personnel and GMP authorisation were required at the point of IND submission.
The implementation of the IND Application simplified both the dossier requirements and the process. This was a turning point for Korea to become an emerging market for clinical research, ranking among the top 10 countries globally for the number of clinical trials conducted.1
IND Review Procedure
Five steps are required:
- Receipt of IND Application dossiers;
- Request for consultation with the Drug Evaluation Department;
- Review of submitted data (including safety data);
- Notification of the review result; and
- Request for supplementation or final decision.2
The review process takes 30 working days. 2
Stepwise IND process for Medicinal Products
The IND submission process in South Korea is both well-defined and highly transparent. Prior to performing a clinical trial in Korea, the applicant should have registered either the Individual Business or Corporate Business.
The applicant must register an account on the MFDS Drug Information Portal https://nedrug.mfds.go.kr for submission of an IND application.
An IND is not required for trials using marketed drugs in Korea within the approved indication. The applicant should submit the IND application and upload the dossier.
The Article 24 of ‘Regulation on Safety of Pharmaceuticals, etc.’ stipulates the following documents:
1. | Development Plan; | |
2. | Investigator’s Brochure; | |
3. | Documents or data which prove that the product was manufactured in compliance with Good Manufacturing Practice (GMP) for Medicinal Products in Annex 1 and GMP for Investigational Products in Annex 4-2. In this case, if the investigational medicinal product falls into one of the following products, documents or data which prove that the product was manufactured in compliance with the relevant GMP shall be additionally submitted. | |
A. | Biological products, etc.: Good Manufacturing Practice for Biological Products, etc. in Annex 3; | |
B. | Radiopharmaceuticals: Good Manufacturing Practice for Radiopharmaceuticals of Annex 3-2; | |
C. | Medicinal high-pressure gases: Good Manufacturing Practice for Medicinal Gases in Annex 3-3; | |
3.1 | In the case of blood pharmaceuticals, documents or data which prove the blood product under Article 2, Subparagraph 8 of the Blood Management Act was manufactured in compliance with GMP for Blood Products in Annex 3-4; | |
4. | Data on the manufacture and quality related to investigational products; | |
5. | Data on the non-clinical trial results; | |
6. | Data on past experiences of a test product to be used for clinical trial (if available); | |
7. | Data on institutions (hereinafter referred to as “clinical trial institution”) that perform clinical trials pursuant to Article 34 (2) 2 of the Act, clinical trial sample analysis institution according to the same Paragraph (hereinafter referred to as “clinical trial sample analysis institution”). Data on investigators, Contract Research Organisation (CRO) etc.; | |
8. | Regulations on compensation for victims of clinical trials; | |
9. | Informed consent form for subjects; and | |
10. | The protocol |
Amendment process in IND of Medicinal products in South Korea
In the event changes are required for an approved IND that fall under any of the following categories, then approval is required:
1. | Changes in the study purpose; | |
2. | Changes to the applicant; | |
3. | A change that significantly affects the safety of subjects or the reliability of the study result, corresponding to any of the following items: | |
A. | As a change in the study population, significant changes in the number of subjects, changes in the inclusion and exclusion criteria of the subjects, or relaxation of the dropout criteria; | |
B. | As a change in the test design, addition or exclusion of experimental group or control group; | |
C. | As a change in the information about investigational products, relaxation of the standards, deletion of test items, or changes of the manufacturer; | |
D. | As a change in the safety and efficacy, changes of endpoints or evaluation methods; or | |
E. | Other changes prescribed by the Minister of MFDS. |
Local Language (Korean) Requirements for IND Dossier
In principle, the MFDS requires a summary in Korean and in the original language for the IND submission dossier.
The documents for the Study Protocol, Informed Consent Form and Compensation Rules for Subjects need to be submitted in the Korean language. Information regarding non-clinical study and clinical experience (if available) require a summary in Korean to be submitted to MFDS. Information regarding Chemistry, Manufacturing and Control (CMC) requires adaptation in accordance with MFDS guidelines in Korean.
In addition, the sections concerning the Development Plan, Information on Clinical Institutions, Laboratories, Investigators and CROs need to be submitted in Korean.
Precision for Medicine in South Korea
South Korea’s robust regulatory structure and well-defined drug development ecosystem, makes it a highly preferred clinical trial destination in the Asia Pacific region. Our team of regulatory and clinical experts in South Korea provide comprehensive support to sponsors throughout their drug development journey, from IND through to NDA submissions.
Are you ready to talk? Precision for Medicine is ready to help.
References
- KoNECT Start with Korea 2023.
- Guide to Drug Approval System in Korea MFDS April 2017