1. Recent Evolution of New Drug Review and Approval System in Korea
September 28, 2000
Soo-Young Choi, Ph.D
Korea Food & Drug Administration
Seoul, Korea

2. New Drug Review and approval Process in Korea
New Drug Regulations in Korea
Korean Good Clinical Practice
Future Perspectives

3. in New Drug Regulations
Major Changes
in New Drug Regulations
Introduction of bridging concepts recommended in the ICH guideline
Permission of multinational/multicenter clinical trials
Implementation of science-based regulations
Protection of rights, safety, and well-being of trial subjects
Assurance of the quality of clinical trials

4. Central Pharmaceutical Toxicological Research
KFDA Organization Chart
Food Safety
Bureau
Pharmaceutical
Safety
Division
Phrmaceutical
Surveillance
Narcotic
Control
Medical
Divices
Pharmacutical Safety
Drug Evaluation Department
Biologics
Evaluation
Department
Natural Medicine
Medical Device
Office of
Safety Evaluation
Commissioner
Deputy commissioner
Central Pharmaceutical
Affairs Council
Planning& Mgmt
6 Regional KFDA
National Institute of
Toxicological Research

5. Safety & Efficacy Evaluation Central Pharmaceutical
Step by Step Review
and Approval Process
Safety & Efficacy Evaluation
Central Pharmaceutical
Affairs Council
Discovery
Preclinical
Development
Phase II
Clinical
Trial
Marketing
Phase I
Phase III
Clinical Trial Approval
Authorization
Consultation

6. New Drug Review and approval Process in Korea
New Drug Regulaion in Korea
Korean Good Clinical Practice
Future Perspectives

7. Major Points of Revision
Introduction of a bridging concept
Permission of multinational/ multicenter clinical trials
Implementation of science-based regulations

8. Introduction of Bridging Concept
Foreign clinical data can be accepted as full
or partial support for approval
Korean Phase III trial is not mandatory
for approval
New drugs can be approved in Korea
with foreign clinical data and appropriate bridging data

9. Requirements for approval
Category
~ 1999
2000 ~
Drugs under development
Drugs with ＜3 years marketing experience or drugs marketed only in one country
Drugs with ≥ 3 years marketing experience in
≥ 2 countries
Phase I, II, III studies in Korea
Phase III clinical study in Korea
No clinical study
Foreign data & bridging data
Foreign data & bridging data from July, 2001
Post Marketing Surveillance (PMS) study is mandatory for new drugs.

10. Submission of Bridging Data For new drugs,
* Appropriate bridging data should be submitted
For the following drugs, however,
the submission of bridging data is not mandatory for approval
Orphan drugs or drugs used to be orphan drugs
Drugs for AIDS or cancer treatment which pose threat to life because of
no standard therapy or failure of a standard therapy, as recognized by
the KFDA
New drugs being developed in or outside Korea for which clinical trials
in Korea are intended
Diagnostics including radioactive drugs
Topical drugs having no systemic effect
Drugs proved to be of no ethnic differences in their safety and efficacy
Any other cases KFDA approves

11. Permission of Multinational /Multicenter Clinical Trials
Clinical study for drugs under development can be conducted in Korea at any stage of clinical development if safety of the drugs in human can be supported by foreign clinical data
- not necessarily conduct a clinical study in Korea from
Phase 1
Approval time of conducting a clinical study can be reduced from 115 days to 60 days by employing a simultaneous review system for clinical study protocol and application of importing or manufacturing investigational drugs
Comparator drugs can be imported as investigational drugs by a third party

12. of science-based regulations
Implementation
of science-based regulations
Abolished a minimum number of investigational sites and subjects required for each phase of a clinical trial
(e.g., a minimum of 3 centers and 90 subjects for a Phase III trial)
Abolished a minimum clinical response rate (e.g., 66.7%) required in the previous regulations
Allowed submission of a minimum stability data to support stability of the drug during a clinical trial
Activated sponsor/regulator meetings to discuss scientific issues occurred during the development phase

13. New Drug Review and approval Process in Korea
New Drug Regulaion in Korea
Korean Good Clinical Practice
Future Perspectives

14. Historical Overview
1987 : Establishment of KGCP Guideline as a self-guideline
1990 : Accreditation of Clinical Trial Hospitals : 82
1992 : New Drug Committee in CPAC
- Advisory Expert Review for Clinical Protocol/Reports
1993 : Governmental Initiatives for KGCP implementation
- Written Informed Consent, Optional IRB Approval
- Inspection(Audit) of Clinical Trial
: Revision of KGCP - enforcement,
2000 : Revision of KGCP - enforcement,
- Almost identical to the ICH E6 Guideline

15. Revision of KGCP
in Jan 2000
<Background>
Harmonization of KGCP with ICH GCP to improve GCP standards
<Major Points of Revision>
Protection of rights, safety and well-being of trial subjects
Assurance of the quality of clinical trials

16. Protection of rights, safety and well-being of trial subjects
A procedure of obtaining informed consent has been described in detail
Items regarding compensation to trial subjects has been provided
It is required to include clergy or lawyer in the IRB
Safety reporting procedure in accordance with the ICH guideline has been introduced

17. Assurance of the Quality of Clinical Trials
Standard operating procedures (SOPs) to achieve uniformity of the performance of clinical trials are required
It is required to implement and maintain quality assurance (QA) and quality control (QC) program for clinical studies
The list of essential documents and their maintenance for the conduct of clinical trials has been specified

18. New Drug Review and approval Process in Korea
New Drug Regulaion in Korea
Korean Good Clinical Practice
Future Perspectives

19. Future Perspective
Our regulations will continuously be revised to facilitate domestic and global development of new drugs
We try to minimize the number of bridging data or studies required for approval as our experience in evaluating bridging data and the scientific evidence accumulate
It is recommended to obtain clinical data in Korean population during the development phase