Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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History|About MFDS|Minisry of Food and Drug Safety

History

2021

The 30th Amendment
The 30th Amendment
Date of Amendment Presidential Decree No. 31489 (25 Feb. 2021), Ordinance of the Prime Minister No. 1679 (26 Feb. 2021)
Summary
  • (Established) Innovative and Diagnostic Medical DEvices Police Division, Emerging Infectious Disease Vaccines Divison
  • (changed) Imported Food Analysis Division of 3 Regional Offices → Food Standard Analysis Division of 3 Regional Offices
Total workforce
  • Reference)1,958 persons, (Operation)2,006 persons
The 29th Amendment
The 29th Amendment
Date of Amendment Presidential Decree No. 31380 (5 Jan. 2021)
Summary
  • Maintenance of difficult legal terminology
Total workforce
  • (Reference)1,956 persons, (Operation)1,964 persons

2020

The 28th Amendment
The 28th Amendment
Date of Amendment Presidential Decree No. 31305 (12 Dec. 2020), Ordinance of the Prime Minister No. 1660 (31 Dec. 2020)
Summary
  • (changed)
    •     Livestock Products Safety Division → Livestock Product Safety Policy Division
    •     Agriculture and Fisheries Safety Division → Agriculture and Fisheries Safety Policy Division
  • Addition of tasks to be performed according to the revision and enforcement of the Pharmaceutical Affairs Act and Medical Device Act
Total workforce
  • (Reference)1,956 persons, (Operation)1,964 persons
The 27th Amendment
The 27th Amendment
Date of Amendment Presidential Decree No. 30965 (25 Aug. 2020), Ordinance of the Prime Minister No. 1640 (31 Aug. 2020)
Summary
  • Increasing the number of people employed by the Occasional Employment System to 18 for the reformation of an approval/review system of pharmaceutical products
  • Newly establishing "Big Data Policy Analysis Team (7 members)" based on Total Labor Cost System (~ July 31, 2023)
  • Carrying out the structural reformation to enhance efficiency of the operation systems by Bureau
Total workforce
  • (Reference)1,956 persons, (Operation)1,964 persons
The 26th Amendment
The 26th Amendment
Date of Amendment Presidential Decree No. 30623 (21 Apr. 2020), Ordinance of the Prime Minister No. 1613 (8 May. 2020)
Summary
  • Reflected on the performance evaluation of new departments
    • Integrated Food Information Service Division → Changed to a regular organization
Total workforce
  • (Reference)1,938 persons, (Operation)1,946 persons
The 25th Amendment
The 25th Amendment
Date of Amendment Presidential Decree No. 30462 (25 Feb. 2020), Ordinance of the Prime Minister No. 1598 (27 Feb. 2020)
Summary
  • Reflected the required number of personnel for 2020 (1 Division, 1 Inspection Office, +48 persons)
    • Established the Sanitary Goods Policy Division and (Regional FDS) Established the Cheonan Imported Food Inspection Office
  • Changed open type positions (1 director-General-level 1, 1 Director-level)
Total workforce
  • (Reference)1,938 persons, (Operation)1,946 persons

2019

The 24th Amendment
The 24th Amendment
Date of Amendment Presidential Decree No. 30282 (31 Dec. 2019), Ordinance of the Prime Minister No. 1587 (9 Jan. 2020)
Summary
  • Designating “Food safety management sector” as a professional civil servant (8 officers)
Total workforce
  • (Reference)1,890 persons, (Operation)1,898 persons
The 23th Amendment
The 23th Amendment
Date of Amendment Presidential Decree No. 29743 (7 May. 2019), Ordinance of the Prime Minister No. 1538 (15 May. 2019)
Summary
  • Established the Narcotics Safety Planning Directorate
Total workforce
  • (Reference)1,890 persons, (Operation)1,898 persons
The 22th Amendment
The 22th Amendment
Date of Amendment Presidential Decree No. 29583 (26 Feb. 2019), Ordinance of the Prime Minister No. 1527 (4 Mar. 2019)
Summary
  • Reflected on the required number of personnel for 2019 (31 officers)
  • Reflected on the performance evaluation of new departments
    • Biopharmaceuticals Review Management Division→ Changed to a regular organization
Total workforce
  • (Reference)1,889 persons, (Operation)1,897 persons

2018

The 21th Amendment
The 21th Amendment
Date of Amendment Presidential Decree No. 29244 (23 Oct. 2018), Ordinance of the Prime Minister No. 1507 (11 Dec. 2018)
Summary
  • Reshuffled the arrangement (Transferred the ‘renewal of medical products’ to regional offices, Integrated the special judicial police affairs of each division to the management support divisions of regional offices)
Total workforce
  • (Reference)1,858 persons, (Operation)1,866 persons
The 20th Amendment
The 20th Amendment
Date of Amendment Ordinance of the Prime Minister No. 1475 (9 Jul. 2018)
Summary
  • Adjustment in the number of Director-General-level)and Director-level hired through open position system
Total workforce
  • (Reference)1,858 persons, (Operation)1,866 persons
The 19th Amendment
The 19th Amendment
Date of Amendment Presidential Decree No. 28752 (30 Mar. 2018), Ordinance of the Prime Minister No. 1452 (30 Mar. 2018)
Summary
  • Reflected the required number of personnel for 2018 (61 personnel)
    • Established Gimpo Imported Food Inspection Center
Total workforce
  • (Reference)1,858 persons, (Operation)1,866 persons
The 18th Amendment
The 18th Amendment
Date of Amendment Ordinance of the Prime Minister No. 1430 (1 Jan. 2018)
Summary
  • Deployed 8 personnel for the operation of the Total Labor Cost System (six -class)
Total workforce
  • (Reference)1,797 persons, (Operation)1,805 persons

2017

The 17th Amendment
The 17th Amendment
Date of Amendment Ordinance of the Prime Minister No. 1419 (28 Sep. 2017)
Summary
  • Changed name of position: Organization and Management Innovation Office → Innovative Administration Office
Total workforce
  • 1,797 persons
The 16th Amendment
The 16th Amendment
Date of Amendment Presidential Decree No. 28021 (8 May. 2017), Ordinance of the Prime Minister No. 1397 (26 May. 2017)
Summary
  • Pharmaceutical Safety Evaluation Division → Changed to a regular organization
Total workforce
  • 1,797 persons
The 15th Amendment
The 15th Amendment
Date of Amendment Presidential Decree No. 27942 (20 Mar. 2017), Ordinance of the Prime Minister No. 1383 (21 Mar. 2017)
Summary
  • Reshuffle relevant bureaus and divisions to strengthen safety management of imported food and to ensure efficiency of food safety management
    • Reshuffle Food Nutrition and Dietary Safety Bureau to Food and Consumer Safety Bureau
    • Reshuffle Agro-Livestock and Fishery Products Safety Bureau to Imported Food Safety Policy Bureau
Total workforce
  • 1,797 persons
The 14th Amendment
The 14th Amendment
Date of Amendment Presidential Decree No. 27891 (28 Feb. 2017), Ordinance of the Prime Minister No. 1360 (28 Feb. 2017)
Summary
  • Increase in the total workforce required for the year 2017 (38 people for three divisions, namely Alcoholic Beverages Safety Management and Planning Division; Narcotics Control Division; Biopharmaceutical Review and Management Division)
Total workforce
  • 1,797 persons
The 13th Amendment
The 13th Amendment
Date of Amendment Presidential Decree No. 27689 (27 Dec. 2016), Ordinance of the Prime Minister No. 1360 (26 Jan. 2017)
Summary
  • Reduction of 15 employees in the total workforce (5 from head office, 4 from NIFDS, 6 from regional offices) in 2016
Total workforce
  • 1,759 persons

2016

The 12th Amendment
The 12th Amendment
Date of Amendment Presidential Decree No. 27143 (10 May 2016), Ordinance of the Prime Minister No. 1308 (29 July 2016)
Summary
  • Adjustment in open competitive positions for the level of director general (including the position of director general of Pharmaceutical Safety Bureau and excluding the position of director general of Food Standard Planning Office)
Total workforce
  • 1,774 persons
The 11th Amendment
The 11th Amendment
Date of Amendment Presidential Decree No. 27143 (10 May 2016), Ordinance of the Prime Minister No. 1255 (19 May 2016)
Summary
  • Increase in the total workforce required for the year 2016 (12 people for one division (Integrated Food Information Service Division)
Total workforce
  • 1,774 persons
The 10th Amendment
The 10th Amendment
Date of Amendment Presidential Decree No. 26790 (30 Dec. 2015), Ordinance of the Prime Minister No. 1255 (05 Feb. 2016)
Summary
  • Adjustment in employee positions (±15 people) is reflected
Total workforce
  • 1,762 persons

2015

  • 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
2015 History
HQ
  • Duties of Health Functional Food Standard Division, Medical Device Quality Division and Novel Food Division (transferred to NIFDS) transferred to other offices or abolished Health Functional Food Policy Division and Medical Device Safety Evaluation Division newly established
Institute(National Institute of Food and Drug Safety Evaluation, NIFDS)
  • Radiation Safety Division abolished
    Novel Food Division(transferred from HQ), In-vitro Diagnostic Division newly created
    Nation Center for Lot Release renamed to Vaccines Division
    Blood Products Team renamed to Blood Products Division
  • Headquarter(1 Planning and Coordination Office, 7 Bureaus, 1 Office, 46 Divisions)
    7 Affiliated Agencies: 1 Institute(6 Departments, 40 Divisions),
    6 Regional Administrations(2 Centers for Food & Drug analysis, 15 Imported Food Inspection Centers)

2014

1 Division(Quasi-drug Policy Division) established in the Headquarter

2013

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, 2013)
    • 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

2012

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)

2011

  • 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

2010

  • 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.

2009

  • 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)

2008

  • 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.

2007

  • Spokesperson system was introduced for the advanced system for the press coverage, KFDA also reinforced its staff and newly created 5 teams.

2006

  • 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.

2005

  • 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.

2004

  • The organization was restructured with the creation of Medical Devices Management Division, and Bio product Technical Support Division

2003

  • KFDA newly established Health Functional Food New Division, Health Functional Food Standardization Division, and Biologics Standardization Division along with the increase in staff

2002

June, 2002
  • The National Center of Toxicological Research was reorganized to National institute of Toxicological Research

1998

February, 1998
  • 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.