The 15th Amendment
|Date of Amendment||Presidential Decree No. 27942 (20 Mar. 2017), Ordinance of the Prime Minister No. 1383 (21 Mar. 2017)|
The 14th Amendment
|Date of Amendment||Presidential Decree No. 27891 (28 Feb. 2017), Ordinance of the Prime Minister No. 1360 (28 Feb. 2017)|
The 13th Amendment
|Date of Amendment||Presidential Decree No. 27689 (27 Dec. 2016), Ordinance of the Prime Minister No. 1360 (26 Jan. 2017)|
The 12th Amendment
|Date of Amendment||Presidential Decree No. 27143 (10 May 2016), Ordinance of the Prime Minister No. 1308 (29 July 2016)|
The 11th Amendment
|Date of Amendment||Presidential Decree No. 27143 (10 May 2016), Ordinance of the Prime Minister No. 1255 (19 May 2016)|
The 10th Amendment
|Date of Amendment||Presidential Decree No. 26790 (30 Dec. 2015), Ordinance of the Prime Minister No. 1255 (05 Feb. 2016)|
- 1 Division and 2 Imported Food Inspection Centers Established
- Headquarter: Pharmaceutical Safety Evaluation Division
- Regional Food and Drug Administration: Incheon Port Imported Food Inspection Center, Yongin Imported Food Inspection Center
- Headquarter and Affiliated Agencies Restructuring by Duty
|Institute(National Institute of Food and Drug Safety Evaluation, NIFDS)||
1 Division(Quasi-drug Policy Division) established in the Headquarter
Ministry of Food and Drug Safety(Status elevated from KFDA)
- Policy-making function regarding food and drug safety of Ministry of Health and Welfare and duties regarding sanitation and safety of agro-livestock fishery
products of Ministry of Ministry for Food, Agriculture, Forestry and Fisheries transferred to MFDS according to revision of 「National Government Organization Act(Mar. 23,
- MFDS has one Headquarter(1 Planning and Coordination Office, 7 Bureaus, 1 Office, 43 Divisions) and 7 Affiliated Agencies(1 Institute (6 Departments, 39 Divisions), 6 Regional Administrations(13 Imported Food Inspection Centers))
- Established 2 Divisions(Alcoholic Beverages Safety Management and Planning Division(temporary), Pharmaceutical Approval and Patent Management Division) in the Headquarter
KFDA has one Headquarter, 7 Affiliated Agencies(1 Institute, 6 Regional Administrations)
- Headquarter : 1 Planning and Coordination Office, 5 Bureaus(1 office and 4 Departments), 53 Divisions
- Institute : 3 Departments, 28 Divisions
- 6 Regional Administrations (8 Imported Food Inspection Centers)
- Established Emergency Planning Office under the Planning & Coordination Bureau.
- Abolished GMP and Quality Research Team under the National Institute of Food and Drug Safety Evaluation.
- Established Biopharmaceutical Quality Management Division under Biopharmaceuticals & Herbal Medicine Bureau.
- Established Cell & Gene Therapy Division under Biopharmaceuticals and Herbal Medicine Evaluation Department
- Changed Advanced Therapy Products Division to Recombinant Protein Products Division
- Reorganized the Medical Devices Evaluation Bureau based on the different clinical fields. Diagnostic Medical Devices Division, Therapeutic Medical Devices Division and Medical Materials and Supplies Division changed to Cardiovascular Devices Division, Orthopedic & Restorative Devices Division, and Dental & Gastroenterology Devices Division
- Established High-Tech Medical Devices Division
- The National Tax Service transferred Liquor Safety Management responsibilities to the KFDA.
- Adverse Effect inspection Team of the Nation Institute Food and Drug Safety Evaluation was abolished and became Pharmaceutical Safety Information Team under Pharmaceutical Safety Bureau of the KFDA.
- Evaluation Science Division of the NIFDS changed their name to Pharmaceutical Standardization Research and Testing Division.
- The KFDA relocated to Osong Health Technology Administration Complex, Osong, ChungBuk during November.
- The KFDA Headquarters was previously comprised of 1 Officer, 5 Bureaus(5 Departments), 65 Divisions, but the composition was changed to 1 Officer, 5Bureaus(1 Officer and 4 Departments), 48 Divisions. Criminal Investigations Office, and Foreign Inspection Division were established.
- National Institute of Toxicological Research was transformed into National Institute of Food and Drug Safety Evaluation(3 Departments, 18 Divisions > 3 Departments, 29 Divisions)
- Innovation Planning Officer, and Laboratory Test Management Team were abolished, and creation and innovation Officer, and Laboratory Audit Team were newly formed instead.
- Headquarters were changed to bureaus, and the Team-based System became Division-based.
- The responsibility of treating and caring narcotic addicts was transferred to the ministry for Health, welfare and Family Affairs.
- Spokesperson system was introduced for the advanced system for the press coverage, KFDA also reinforced its staff and newly created 5 teams.
- Bureau for Risk Management, information Management Team, Customer Support Team, Novel Food Team, Clinical Management Team, Herbal Medicine Management Team, Cosmetics Evaluation Team, Biologics Management Team, Herbal Medicine Evaluation Team, Medical Devices Quality Management Team were founded.
- The organization of 2 Offices, 2 Bureaus, and 6 departments was restructured into 6 Headquarters, and 4 Departments.
- Team based system was introduced to all Divisions.
- The organization was restructured with the creation of Medical Devices Management Division, and Bio product Technical Support Division
- KFDA newly established Health Functional Food New Division, Health Functional Food Standardization Division, and Biologics Standardization Division along with the increase in staff
- The National Center of Toxicological Research was reorganized to National institute of Toxicological Research
- The Food and Drug Safety Administration was newly established and there were affiliated agencies such as national toxicology laboratory and six regional food and drug safety administrations.