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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 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 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
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