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영문목차

I. Outline=11

1. Vision-Objective-Core Strategies=13

2. Organization-Affiliated Organizations=14

3. History=16

II. Food=19

Section 1. Strengthening of the Food Safety Management System=20

1. Cooperation between Government Bodies to Eradicate Unwholesome Food=20

2. Strengthening of Food Production and Manufacturing Safety=25

3. Improving the Level of Safety Management for Foods Being Distributed and Consumed=34

4. Strengthening Safety Management of Imported Foods=44

5. Establishment of an Alcoholic Beverage Safety Management System=54

Section 2. Internationalization of Scientific Food Standards and Specifications=58

1. Improving Food Safety Standards and Specifications=58

2. Improving and Reinforcing Standards and Specifications on Food Additives, Equipment, Containers and Packaging=61

Section 3. Expansion of Healthy Dietary Environment=64

1. Strengthening Food Safety Management=64

2. Reduction of Food Poisoning through Development of a Safe Eat-out and Meal Service Environment=70

3. Improving the Regulation of Health Functional Foods and Invigoration of the Market=72

4. Strengthening of Safety Management of National Nutrition=76

III. Medicinal Products=81

Section 1. Medicine=82

1. Introduction and Stabilization of GMP that is in Harmony with International Standards=82

2. Internationalization of Medicine Approval and Evaluation System=85

3. Strengthening Safety Management of Approved Pharmaceuticals=93

4. Strengthening the Competitiveness of the Pharmaceutical Industry by Stable Operation the Patent-Regulatory Approval Linkage System=99

5. Establishment of a Management System for Preventing Abuse and Misuse of Narcotic Drugs=100

Section 2. Biopharmaceuticals and Cosmetics=104

1. Safety Management and Quality Improvement of Biopharmaceuticals (Human Tissues)=104

2. Safety Management of Herbal and Natural Medicine=109

3. Consumer-Centered Safety Management of Cosmetics and Quasi-Drugs=111

4. Realizing the Creative Economy to Support Korean Biopharmaceutical Industry's Advancement into the Global Market=117

5. Establishment of an Advanced Approval and Evaluation System for Biopharmaceuticals=121

Section 3. Medical Devices=128

1. Establishment of a Support System for Quick Commercialization of Medical Devices=128

2. Advancement of Consumer-Centered Medical Device Safety Management System=131

3. Establishment of a Safety Evaluation System for Medical Devices=132

4. Advancement of Medical Device Approval Review Process=134

IV. Risk Prevention=141

Section 1. Establishment of a Basis for Consumer-Focused Preemptive Risk Prevention and Crisis Response System=142

1. Establishing a Basis for Preventing Safety Accident=142

2. Establishing a Food and Drug Safety Management System through Precautionary Safety Management=143

3. Strengthening Cooperation with Consumer-related Organizations and Groups=145

Section 2. Promoting Food and Drug Safety Consensus by Strengthening On-site Communication=147

1. Promoting Communication with the Public=147

2. Establishing and Operating a Communication Network=147

3. Operating Public Experiential Programs=148

Section 3. Enhancing Transparency, Sharing and Use of Food and Drug Safety Information=150

1. Collecting, Analyzing and Utilizing Food and Drug Safety Information=150

Section 4. Enhancing International Competitiveness through the Advancement of Testing and Inspection Agencies=154

1. Overview of Testing and Inspection Agencies=154

2. Designation and Follow-up Management of Testing and Inspection Agencies=154

3. Improved Reliability & Advanced Management System of Testing and Inspection Agencies=154

V. Research and Development for Food and Drug Safety=159

Section 1. Research and Development that are Directly Linked to Safe Life=160

1. Improvement of Food and Drug R&D=160

2. Impartial Research Management and Provision of Services for Researchers=161

3. Outcome Management for Effective Research and Development Projects=162

Section 2. Expanding Risk Assessment for Scientific Food Safety Management=164

1. Improvement of Risk Assessment System with Expanded National and International Cooperation=164

2. Advancement of the Risk Assessment System for Residual Substances in Agricultural, Livestock and Marine Products=164

3. Strengthening the Scientific Basis for Reducing Hazardous Pollutants in Food=165

4. Research and Development of Expeditious and Precise Microbial Testing Methods=166

5. Strengthening Safety Management of Food Additives, Utensils, Containers and Packaging=168

6. Establishing a Basis for Managing the Safety of Food Nutrition, Dietary Life and Functional Health Foods=169

7. Scientific Surveillance of Food Adulteration and Food Fraud=169

Section 3. Development of Safety Assessment Technologies for Supporting the Medicinal Products Safety Management System=171

1. Research on Advancement of Pharmaceutical Safety Management=171

2. Research on Biopharmaceutical Safety Management=172

3. Research on Herbal Medicine Safety Management and International Cooperation=172

4. Research on Standards, Specifications and Risk Assessment of Cosmetic and Quasi-Drug=173

5. Research on Prevention and Safety Management of Infectious Diseases=175

6. Research on Medical Device Quality and Safety Management=175

Section 4. Development of Safety Evaluation Technologies for Food and Drugs=176

1. Government Control of Toxic Substances and International Cooperation in Toxicity Testing Methods=176

2. Development of Alternatives to Animal Testing and Advancement of Non-Clinical Tests=177

3. Research on Predictability of Drugs and Assessment of Pharmaceutical Dependence=178

4. Securing Public Health and Safety through Advancement of Clinical Evaluation and Reduction of Adverse Events=179

5. Preventing Adulterated Food and Drugs through an Advanced Analysis System=180

6. Establishment of a System for Development, Preservation and Utilization of Laboratory Animal Bio Resources (BIOREIN : Bio Resources Initiative)=180

Section 5. Advancement and Strengthening of Expertise in the National Lot Release System=182

1. Current Status of the National Lot Release System and Regulatory Improvements=182

2. Strengthening Cooperation and Communication through the Operation of Public-Private Consultative Group=183

3. International Cooperation Activities=184

4. Strengthening the Quality Management Function in National Testing and Operation of Proficiency Program=185

VI. Appendix=187

1. Changes in the Number of staff=188

2. Ministers/Commissioners/Vice Ministers in MFDS=194

3. The Roles and Responsibilities(HQ)=196

4. Number of Staff=200

5. Laws and Regulations under the Ministry of Food and Drug Safety=203

6. Contributors=204

Table of Contents

Table 1-1-1. HACCP Certification Status=26

Table 1-1-2. Consumer Awareness of the HACCP System=27

Table 2-2-1. Evaluation of Cell and Gene Therapy Products (2011~2015)=125

Table 4-5-1. National Lot Release Statistics in the Last 5 Years=182

Image of Contents

Image 1-1-1. Pan-Governmental Commitee for Eradicating Unwholesome Food=21

Image 1-1-2. Plan for the 2016 Planned Monitoring=23

Image 1-1-3. Flow Chart of the Hazardous Food Sales Prevention System=36

Image 1-1-4. Structure of Linking Food History Tracking & Management System=38

Image 1-1-5. Implementation Phases of the 'Food-related Equipment Labeling System' by Material Type=42

Image 1-3-1. Operation of the Centers for Children's Food Service Management=66

Image 2-1-1. Narcotics Information Management System=102

이용현황보기

Ministry of Food and Drug Safety white paper. 2016 이용현황 표 - 등록번호, 청구기호, 권별정보, 자료실, 이용여부로 구성 되어있습니다.
등록번호 청구기호 권별정보 자료실 이용여부
0002168841 363.19 -A16-1 2016 서울관 서고(열람신청 후 1층 대출대) 이용가능

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