Professional Documents
Culture Documents
Myung-soo Ahn
Ministry of USC
Food and Drug Safety Regulatory Science
Contents
1. Introduction of Korea
2. Introduction of MFDS
3. Korean Pharmaceutical Industry
4. Characteristics of Korean System
5. Regulatory pathways of pharmaceuticals
6. Regulatory pathways of medical devices
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Myung Soo Ahn Drug and Device Development in Korea
Where is Korea?
East Sea
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Myung Soo Ahn Drug and Device Development in Korea
1962 ~ Industrialization
(Miracle on the Han River)
1987 ~ Democratization
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Myung Soo Ahn Drug and Device Development in Korea
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Myung Soo Ahn Drug and Device Development in Korea
Food
Culture
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Myung Soo Ahn Drug and Device Development in Korea
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Myung Soo Ahn Drug and Device Development in Korea
1. Introduction of Korea
2. Introduction of MFDS
3. Korean Pharmaceutical Industry
4. Characteristics of Korean System
5. Regulatory pathways of pharmaceuticals
6. Regulatory pathways of medical devices
1,413 Reorganization
2009 National Center of Toxicological Research was expanded and reorganized to
National Institute of Food and Drug Safety Evaluation
(3 departments 18 divisions 3 departments 29 divisions)
1,449
Nov 2010 Relocation of Headquarters to Osong from Seoul
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Myung Soo Ahn Drug and Device Development in Korea
Scope in responsibilities
Food, Dietary Supplements, Drugs, Bio-pharmaceuticals
Korean traditional(herbal) medicine, Quasi-drugs,
Cosmetics, Cosmeceuticals, Medical devices
Organization
• Headquarters : 7 Bureaus, 46 Divisions
• National Institute of Food and Drug Safety (NIFDS)
• 6 Regional FDA
Staff (1,762)
• Headquarters : 577
• NIFDS: : 406
• Regional KFDA(6) : 774
Regional - FDA
6 Regional Food and Drug Administration
Seoul
-FDA
Gyungin
-FDA
Daejeon
-FDA
Daegu
-FDA
Gwanju Pusan
-FDA -FDA
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Myung Soo Ahn Drug and Device Development in Korea
Spokesperson
Vice
Minister
Criminal Investigation General Services
Office Division
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Biopharmaceu- Pharmaceutical
Toxicological
Food Safety Drug Evaluation ticalsand Herbal Medical Device and Medical Evaluation and
Evaluation Department Medicine Evaluation Device
Department Research
Evaluation Department Research Department
Department Department
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Myung Soo Ahn Drug and Device Development in Korea
1. Introduction of Korea
2. Introduction of MFDS
3. Korean Pharmaceutical Industry
4. Characteristics of Korean System
5. Regulatory pathways of pharmaceuticals
6. Regulatory pathways of medical devices
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Myung Soo Ahn Drug and Device Development in Korea
https://youtu.be/TEW94qhSVPA
Global
Active
New Drugs
New Drug
Beginning of Development
New Drug
Formulation Development 2010s
Domestic Technology
Industry 2000s
Development 1990s
1960/70s GCP
Advancement Assessment of
PIC/S(2014)
(2000)
IND(2001)
Implement the
DMF(2002) regulation of
GCP(1995) Compaensation
on the damage
GLP(2003) caused by side
GMP(1994) effect of
GMP pharmaceuticals
Advancement (2014)
(2008)
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Myung Soo Ahn Drug and Device Development in Korea
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Drug Clinical
Development Trials Market Scale
World’s 10th Country Market Share of City $16 Billion (2015) Export
getting Approval By Total Site Number
from FDA with LGLS $2.4 Billion (2015)
“factive”(2003) Seoul : 1st(2012-2014)
2nd (2015)
27 New Drugs (2016)
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Myung Soo Ahn Drug and Device Development in Korea
18,000
30.2 30.0
16,000 27.6
25.2 28.8 28.0
27.0 27.1
23.3 23.6 25.5 25.0
14,000
21.7
19.6 21.3
22.6
12,000
17.8 20.0
10,000
15.0
8,000
6,000 10.0
4,000
5.0
2,000
0 0.0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014
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Myung Soo Ahn Drug and Device Development in Korea
1. Introduction of Korea
2. Introduction of MFDS
3. Korean Pharmaceutical Industry
4. Characteristics of Korean System
5. Regulatory pathways of pharmaceuticals
6. Regulatory pathways of medical devices
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Myung Soo Ahn Drug and Device Development in Korea
Regulatory Hierarchy
• enforcement of PAA
• drug safety regulation
(GMP, GCP, GSP etc)
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Regulatory Statutes
PAL (1953) : Drugs, Quasi-drugs, Medical devices, Cosmetics
Cosmetics/
Cosmeceuticals(2000)
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Myung Soo Ahn Drug and Device Development in Korea
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Myung Soo Ahn Drug and Device Development in Korea
Product
Manufacturing product license Import product license
(notification) (notification)
* Bridging Study
* CPP: new drug (2014)
Labelling is not premarket review
Local GMP audit for import product
It is illegal selling drugs online
Veterinarian drugs are regulated by the Ministry of
Agriculture, Food and Rural Affairs (MAFRA)
Regulatory Authorities
Ministry of Ministry of
Food and Drug Safety Health and Welfare
(MFDS) (MOHW)
Clinical(Pre-clinical), Distribution,
Premarket approval, Retailing(dispensing)
Postmarket audit Classification,
Insurance(HTA, coverage)
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Myung Soo Ahn Drug and Device Development in Korea
HIRA
NHIS
(Health Insurance Review &
(National Health Insurance Service)
Assessment )
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Myung Soo Ahn Drug and Device Development in Korea
MFDS
MOHW
Premarket Safety/Efficacy Premarket
Review Confirm Approval
Safety/Efficacy Notification
Standards (30 days)
GMP
Manufacturer
Price
Price Negotioation
Application (60 days)
Benefits
HIRA Assessment NHIS
(120-150 days)
Negative Positive
• All medical services, drugs, • Grant benefits selectively to
medical are divided into two products offering excellent
categories: targeted healthcare treatment and high economic
benefits and targeted non- 2006
value
healthcare benefits.
Economic Evaluation
Introduction of positive listing (included in the benefit
package) based on cost effectiveness, starting in 2006.
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Myung Soo Ahn Drug and Device Development in Korea
HIRA NHIS
New Drug (Pharmaceutical Benefit (Negotiation)
Assessment Committee)
HIRA
Generic
(Benefits Standard)
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Myung Soo Ahn Drug and Device Development in Korea
Pharmaceuticals on Listing
Year ’08.1 ’09.1 ’10.1 ’11.1 ’12.1 ’13.1 ’14.1 ’15.1 ’16.1
Listing
15,223 14,900 14,883 14,410 13,814 14,576 15,734 17,115 20,401
Products
1. Introduction of Korea
2. Introduction of MFDS
3. Korean Pharmaceutical Industry
4. Characteristics of Korean System
5. Regulatory pathways of pharmaceuticals
6. Regulatory pathways of medical devices
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Myung Soo Ahn Drug and Device Development in Korea
Non- Clinical
Approval/ Manufacture
Distribution Medication
clinical Review (Import)
• Summary • Consumer
Animal Subjects • Safety & Efficacy Protocol • Health
Evaluation Review for Professionals Safety
• Manufacturer
Set Manufacture/ • Quality & Biologics Issues
Quality Standards Reliability • Importer (Doctors,
• Hospitals Pharmacists
Verification • Pharmacies etc.)
Research &
Development • Wholesalers
(Safety Letters)
Quality
Inspection
Clinical Trials Approvals Manufacture(Import) Safety Inform.
Distribution Management
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Myung Soo Ahn Drug and Device Development in Korea
Drug Classification
• Origin of Ingredients
Chemical, Biological, Herbal
• Public Accessibility
Prescription, OTC (pharmacy)
Safe-and-readily-available drugs (CVS)
• Data Requirements
Routes Classification Drugs Comparisons
Generic Drugs
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Myung Soo Ahn Drug and Device Development in Korea
Pre-IND Pre-NDA
Meeting Meeting
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Myung Soo Ahn Drug and Device Development in Korea
NIFDS
(Drug Evaluation
Department )
Applicant NIFDS NIFDS
• Report Review
• Efficacy, Safety
• Quality Evaluation
• DMF
Sponsors have submitted application as electronic documents through online system for
Pharmaceutical application since Oct. 2nd, 2006
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Myung Soo Ahn Drug and Device Development in Korea
Non Clinical
Clinical
CMC Pharmacology Phase I Bridging DMF CPP,
ADME Phase II etc
GMP ToxicologyPhase III
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Myung Soo Ahn Drug and Device Development in Korea
Bridging Concept
Ethnic Sensitivity
Intrinsic factor
Approval (genetic) Foreign Clinical Data
in Korea Extrinsic factor Bridging Data
(culture, the
environment)
1. Application of BE protocol
3. Conduct of BE study
BE Study except for parenteral use
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Myung Soo Ahn Drug and Device Development in Korea
1. Introduction of Korea
2. Introduction of MFDS
3. Korean Pharmaceutical Industry
4. Characteristics of Korean System
5. Regulatory pathways of pharmaceuticals
6. Regulatory pathways of medical devices
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Myung Soo Ahn Drug and Device Development in Korea
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Myung Soo Ahn Drug and Device Development in Korea
MD Regulations
Regulatory pathways
Notification
Certification
Approval
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Myung Soo Ahn Drug and Device Development in Korea
Competent Authorities
MDITAC* NIFDS
* GMP requirements
Certification Issue Approval Issue
(5 days) (10 days)
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Myung Soo Ahn Drug and Device Development in Korea
Documents related to quality of medical devices, such as, functions, safety. etc.
- Including information on raw materials, structure, purpose of use, instruction for use,
principles of functions, precautions for use, test standards, etc.
Data on raw materials,
Characteristics, purpose of use,
operation method, mechanism,
precautions, test specification,
etc
Technical files
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Myung Soo Ahn Drug and Device Development in Korea
Technical
Documents Tech. file Review Documents Review
GMP Certi. issue
(25days) (5days)
Certi.
Tech. files
3rd Parties MDTAC
Class III, IV
Technical
Tech. file Review Documents Review
Documents
(55days) (10days)
GMP Tech. files
Certi. Tech. file & documents Review (GR, 65days)
Approval issue
Clinical Trial Report
NIFDS
STED (class IV)
Clinical Trial Reports Review(SER, +15days)
Application Application
STED : Summary Technical Documentation
for demonstrating conformity to the
safety and performance of medical
STED devices
: proposed by GHTF(IMDRF)
including design verification, risk
analysis & manufacturing process
Accompanying Accompanying regarding safety and performance
documents documents
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Myung Soo Ahn Drug and Device Development in Korea
Approval process
▪ Plan (protocol)
▪ Technical
Document
Review submission (30 days) Approval
▪ Site description
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