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Information
News&Notice
News&Notice
Card News
Photo News
COVID-19
Latest COVID-19 News
Diagnostics Devices, MFDS-regulated Mask Information
International Cooperation
Overview
Bilateral Cooperation
International Harmonization
Notification to WTO TBT and WTO SPS
Information for Multicultural Family
International Risk Information
Our Works
Food
Food Safety
Imported Food Safety
Promoting Healthy Diets and Safe Food Consumption
Food Labeling System
Regulations
Products
Drugs
Approval Process
Regulations
Products
Drugs Certificate Verification
Bio&Cosmetics
Approval Process
Regulations
Manufactures
Biosimilar
Bio&Quasi-drugs Certificate Verification
Medical Devices
Approval Process
Regulations
Products
Medical Devices Certificate Verification
Management of Testing and Inspection Agencies
Inspection Procedures of Testing and Inspection Agencies
Foreign Testing Laboratory
About MFDS
History
Minister's Message
Former Ministers and Commissioners
Organization
Ministry of Food and Drug Safety
National Institute of Food and Drug Safety Evaluation
Regional Office of Food and Drug Safety
Location
Related Organization
Drugs
Bio&Cosmetics
Medical Devices
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MINISTRY OF
FOOD AND DRUG SAFETY
Safe Food & Drugs, Healthy People
Latest COVID-19 News
Diagnostics Devices,
MFDS-regulated Mask Information
COVID-19,
CDC, Republic of Korea
Our Works
Food
Regulations
Standards and Specifications for Utensils, Containers and Packages(No. 2020-43)
Food Additives Code(#2020-59, 2020.07.10.)
Korean version of Canada's Food safety preventive control plan checklist
Food and livestock products Safety Management Certification Standard(HACCP) [MFDS notice 2020-15]
Labeling Standards for Genetically Modified Foods(No. 2019-98, October 28, 2019)
Standards and Specifications for Utensils, Containers and Packages(2019-2, 20190109)
Labeling Standards of Foods, Etc.(October 28, 2019)
Food Safety
Imported Food Safety
Promoting Healthy Diets and Safe Food Consumption
Food Labeling System
Regulations
Products
Drugs
Regulations
Regulation on the Registration of Active Pharmaceutical Ingredient
Regulation for Pharmaceutical Approvals, Notifications and Reviews
Good Laboratory Practice
Regulation on Pharmaceutical GMP
Regulation on Fees for Pharmaceutical Approval, etc.
Designation of Pharmaceuticals Required to Have Pharmaceutical Equivalence
Regulation on Approval for Investigational New Drug Application of Drugs
Approval Process
Regulations
Products
Drugs Certificate Verification
Bio &
Cosmetics
Regulations
(Advanced Biopharmaceutical Products) Guideline on Quality Assessment for Gene-editing Based Advanced Therapy Medicinal Products
(Advanced Biopharmaceutical Products) Guideline on Nonclinical Assessment for Gene Therapy Products
(Quasi-drugs) Guideline for Measurement Method of Harmful Ingredients in Cigarette-type Smoking Craving Suppressant
(Quasi-drugs) Guideline to Efficacy Test Method of Mite Repellent
(Quasi-drugs) Guideline to Efficacy Evaluation of Mosquito Repellent
(Quasi-drugs) Evaluation Guideline for Sterile Quasi-Drugs
(Quasi-drugs) Guideline on Establishment of Test Item in Preparation of Standards and Analytical Methods of Quasi-Drugs
Approval Process
Regulations
Manufactures
Biosimilar
Bio&Quasi-drugs Certificate Verification
Medical
Devices
Regulations
Guideline on the Review and Approval of In Vitro Diagnostic Devices for COVID-19
Guideline on Review and Approval of Digital Therapeutics (For Industry)
Guideline on Review and Approval of Artificial Intelligence(AI) and big data-based Medical Devices (For Industry)
Guideline on Review and Approval for Cybersecurity of Medical Devices (For industry)
Act on In Vitro Diagnostic Medical Devices
Brochure for Korean Medical Device(English Version)
Guidance on Patient-matched Medical Devices manufactured using 3D printers
Approval Process
Regulations
Products
Medical Devices Certificate Verification
Certificate
Verification
Drugs
Cosmetics
Quasi-drugs
Medical Devices
News & Notice
Key features and mechanism of action of COVID-19 vaccines [Press Release, Jan 22, 2020]
2021-01-15
MFDS begins review of Astrazeneca’s COVID-19 vaccines [Press Release, Jan 4, 2021]
2021-01-08
[Press Release, Dec 31, 2020] COVID-19 vaccine developed in Korea approved for clinical trial (Phase I/II)
2021-01-07
[Press Release, Dec 29, 2020] MFDS begins review of Celltrion’s COVID-19 monoclonal antibody therapy
2021-01-05
[Press Release, Dec 22, 2020 ] MFDS begins rolling reviews of Janssen’s (Johnson&Johnson’s) COVID-19 vaccine
2020-12-29
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News and Notice more information
Photo
[Dec. 16, 2020] Business Agreement Signing Ceremony between the MFDS and Chungbuk National University Hospital
[Dec. 10, 2020] A visit to the COVID-19 diagnostic reagent manufacturer
[Dec. 02, 2020] The 19th International Anti-Corruption Conference (IACC)
[Nov. 20, 2020] A Commemorative Ceremony of the 13th Day of Medical Device
[Nov. 18, 2020] A Commemorative Ceremony of the 34th Day of Medicine
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