South_Korea_Clinical_Trial_Regulatory_Process_Credevo

South Korea is a well-reputed country with lots of years of clinical research to its credit. In fact, it has a long history of conducting global clinical trials than most other Asian countries including Japan. More than 80% of clinical trials conducted in South Korea are global, which is a great indicator of the suitability of South Korea as a clinical trial destination.

South_Korea_Clinical_Trial_Regulatory_Process_Credevo

Why SOUTH KOREA?

Trials from the emerging market of South Korea saw a 5% increase in 2013. At present 8,589 clinical studies are going in South Korea with 1,777 studies recruiting currently [Ref: clinicaltrials.gov]. The growth rate is expected to reach 4% by 2018, mainly due to increased emphasis on drug safety data, new demand for health economics outcomes research, and shift towards personalized medicine and orphan drug.

Here are some interesting facts about South Korea

  1. It is a clinical trial destination with world-class medical infrastructure, a highly-educated, relatively wealthy, and healthy population.
  2. Trials in South Korea generally take place in the well-resourced hospitals, where adherence is maintained due to a high degree of professionalism and a culture of deep respect between patient and physician.
  3. Several electronic resources have been introduced, like clinical trials e-registration system which immediately opens after IND approval, and a self-registration system for contract research organizations (CROs).

All of these factors contribute to a country with one of the shortest startup times in Asia.

Click here to learn about orphan drug regulatory benefits and financial incentives provided by South Korean regulatory

Clinical trial regulatory process in SOUTH KOREA

  • The Korean 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.
  • The MFDS provides pre-investigational new drug consultation services.
  • To conduct a clinical trial in Korea, the sponsor must obtain institutional review board (IRB) approval.  
  • The sponsor should submit a clinical trial application with the appropriate supporting documents, all of which should be translated into Korean.
  • The IRB approval process can take 1-2 months in Korea.

Do you have any queries or looking for regulatory support in various stages of drug development? talk to us at helpdesk@credevo.com or provide your query details in the below form

Requirements to obtain approval for clinical trial initiation

Clinical trials for medical devices in Korea

  • To submit a clinical trial application for a medical device in Korea, foreign companies must first prepare a clinical investigation plan, along with documents proving that Good Manufacturing Practice (GMP) standards are met by the foreign company’s manufacturing facility.
  • If the device is used to treat life-threatening illnesses, a series of supplementary documents must be sent to the Investigational Review Board (IRB) for approval as well. Medical devices trials normally take only 30 days to be approved in Korea.

Clinical trials for pharmaceuticals in Korea

  • Companies must go through the clinical trial authorization (CTA) process.
  • Before beginning the pharmaceutical clinical trial in Korea, applicants must choose trial sites and a Principal Investigator (PI).
  • Korean PIs must be well educated, trained, and have foreign language abilities.
  • The sponsor and head of the clinical trial site will sign a written contract before the trial begins.
  • If a CRO is used, the sponsor must write a contract outlining a set of tasks for the CRO to complete.

Local representative

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 established in Korea.

Electronic Filing System (KiFDA)

Korea’s drug clinical trial approval forms can now be submitted through the e-registration system. Applicants and CROs can self-register their products after receiving approval.

CRIS (Clinical Research Information Services)

  • The Clinical Research Information Service (CRIS) is a non-profit online registration system for clinical trials (researches) in Korea.
  • The CRIS includes any clinical trial or research which will prospectively conduct with human participants, aiming to prevent, detect, diagnose, or treat diseases. 
  • The clinical trial should be approved by the IRB before registration on the CRIS
  • It has been established at the Korea Centers for Disease Control and Prevention (KCDC) with support from the Ministry of Health and Welfare (MOHW). 
  • It joined the WHO International Clinical Trials Registry Platform (ICTRP) as an 11th member of Primary Registry.

Parallel approval process

In South Korea, the application process for both CTA (KiFDA) and IRB are parallel.

Time of approval

Process for RA takes about 30 days and for IRB, it takes about 50 days.

South_Korea_Clinical_Trial_Approval_Process_Credevo

Figure 1

Legends: ICF-informed Consent Form; IB-investigator Brochure; CRF-case Report Form; CMC-chemistry, Manufacturing And Controls

Guidelines to clinical trial approval (CTA) for drugs

See the guideline here

This guidelines includes

  1.    Data to be submitted, etc.
  2.    Preparation of Data to be submitted
  3.    Scope of Data to be submitted       
  4.    Development plan
  5.    Introduction
  6.    Information on the evidence of chemical structure and the physicochemical and biological properties (including a placebo)
  7.    Data on results of non-clinical tests
  8.    Data on efficacy and general pharmacology
  9.    Data on absorption, distribution, metabolism and excretion
  10.  Data on toxicity
  11.  Test data on single-dose toxicity
  12.  Test data on repeated-dose toxicity,
  13.  Test data on genetic toxicity,
  14.  Test data on reproductive and developmental toxicity
  15.  Test data on carcinogenicity
  16.  Test data on other toxicity depending upon characteristics of a test substance (local toxicity, dependency, antigenicity, immunological toxicity, etc.)
  17.  Data on results of clinical trial (if available)
  18.  Clinical trial protocol
  19.  List of References
  20.  Investigator’s Brochure

Requirements for Information to be submitted

  1.    Development Plan
  2.    Introduction
  3.    Data on the evidence of chemical structure and the physicochemical and biological properties (including a placebo)
  4.    Data on results of non-clinical tests
  5.    Data on results of the clinical trial
  6.    Clinical trial protocol
  7.    Investigator’s Brochure

Exemption from submission of data for the category of drugs below

  • A drug under development in Korea is for the first time in the world
  • A drug under development in any foreign country
  • In case the applicant had a prior consultation with the Commissioner of KFDA on the appropriateness of conducting the clinical trial as provided in Article 14 hereof before applying for Clinical Study Authorization, and the appropriateness thereof is acknowledged.
  • In the case of the clinical trial to be conducted for meeting the permit conditions after the license of the drug is issued.
  • An orphan drug
  • A drug with sufficient clinical grounds in Korea and foreign countries, in case the applicant intends to commence a therapeutic confirmatory clinical trial directly/indirectly associated with licensing the drug (including any amendment).
  • A new drug of the natural substance(s) (excluding a case that any characteristic component is separated and extracted).
  • A drug containing a component(s) that has ever been used in Korea that is different from an existing drug(s) containing it in indication and usage, posology and method of administration, composition, formulation and/or the administration route thereof and having no particular problem in safety.
  • Other drugs acknowledged separately by the Commissioner of KFDA. [2]

After approval

Companies must execute further steps, including

  • Receiving approval from an Institutional Review Board (IRB), 
  • Recruiting subjects and trial personnel, and 
  • Ensuring quality standards, etc. Companies should use the MFDS consulting services for pre-investigational new drugs to determine which documents will be needed.

Import of investigational medicines

  • An import permit will be required before the investigational product is shipped into Korea. 
  • The 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 Korea Customs Service.

Procedural requirements

Clinical trials must be conducted following the standards under the Good Clinical Practices for pharmaceutical products and medical devices.

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References

  1. https://www.clinicalleader.com/doc/south-korea-sprinting-clinical-trial-development-0001
  2. https://clinicaltrials.gov/ct2/results?cntry1=ES%3AKR
  3. http://www.appliedclinicaltrialsonline.com/south-korea-next-emerging-early-phase-destination
  4. http://www.pacificbridgemedical.com/regulatory-services/medical-device-pharmaceutical/clinical-trials/korea/
  5. https://cris.nih.go.kr/cris/en/use_guide/cris_introduce.jsp
  6. http://www.appliedclinicaltrialsonline.com/conducting-clinical-trials-asia-0
  7. https://www.slideshare.net/terrybear11/ind-process-and-global-clinical-trials-in-korea
  8. https://www.nihcollaboratory.org/sites/CbyC/Document%20Library/KFDAguidelines.pdf
  9. www.nifds.go.kr/_custom/nifds/_common/board/download.jsp?attach_no=23002

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