Address: Japan, 〒100-0013 Tokyo, Chiyoda 霞が関１丁目２−２ 中央合同庁舎第５号館Phone:+81 3-5253-1111
The Ministry of Health, Labour and Welfare (厚生労働省 Kōsei-rōdō-shō?) is a cabinet level ministry of the Japanese government. It is commonly known as Kōrō-shō (厚労省) in Japan. This ministry provides regulations on maximum residue limits for agricultural chemicals in foods, basic food and drug regulations, standards for foods, food additives, etc.
It was formed with the merger of the former Ministry of Health and Welfare or Kōsei-shō (厚生省) and the Ministry of Labour or Rōdō-shō (労働省).
The Minister of Health, Labour and Welfare is a member of the Cabinet. The current minister is Yoko Komiyama.
The Ministry of Health, Labour, and Welfare (MHLW) (Koseirodosho in Japanese) was established by a merger of the Ministry of Health and Welfare (MHW) and the Ministry of Labour, on January 6, 2001 as part of the government program for reorganizing government ministries. The MHLW, which was originally established in 1938, has been in charge of the improvement and promotion of social welfare, social security and public health, and the new organization has the same tasks.
It consists of the ministry proper, affiliated institutions, councils, local branches, and an external organization. The ministry proper includes the Minister’s Secretariat, 11 bureaus, and the Director-General for Policy Planning and Evaluation. Councils include the Social Insurance Council, Pharmaceutical Affairs and Food Sanitation Council (PAFSC), and other organizations. Affiliated institutions include national hospitals and the National Institute of Health Sciences. Local branches are regional bureaus of health and welfare and prefectural labor bureaus. The external organizations are the Social Insurance Agency and the Central Labor Relations Commission (Fig. 1. Organization of Ministry of Health, Labour, and Welfare).
The MHLW is in charge of pharmaceutical regulatory affairs in Japan (veterinary drugs are under the jurisdiction of the Ministry of Agriculture, Forestry and Fisheries), and the Pharmaceutical and Food Safety Bureau (PFSB) undertakes main duties and functions of the Ministry: it handles clinical studies, approval reviews and post-marketing safety measures, i.e., approvals and licensing.
The Health Policy Bureau handles promotion of R&D, production, distribution policies, and drug pricing, i.e., functions related to pharmaceutical companies. The Pharmaceuticals and Medical Devices Evaluation Center (Evaluation Center) in the National Institute of Health Sciences was established to strengthen approval reviews on July 1, 1997.
To confirm the reliability of reviews and application data, the Organization for Pharmaceutical Safety and Research (OPSR) conducted compliance reviews on application data. The OPSR also began offering consultation services on protocols at the clinical trial stage.
This was followed by the integration of the aforementioned Evaluation Center, OPSR, and part of the Medical Devices Center on April 1, 2004 to form a new independent administrative organization, the Pharmaceutical and Medical Devices Agency (PMDA, KIKO). The role of the PMDA is to provide consultations concerning the clinical trials of new drugs and medical devices, and to conduct approval reviews and surveys of the reliability of application data.
Following this reorganization, the MHLW and PMDA handle a wide range of activities from clinical studies to approval reviews, reviews throughout post-marketing stage, and pharmaceutical safety measures (Fig. 2. Organization of Pharmaceutical and Food Safety Bureau (PFSB) and Pharmaceuticals and Medical Devices Agency (PMDA). ,………….http://www.jpma.or.jp/english/parj/pdf/2012.pdf
Pharmaceuticals and Medical Devices
■ Strategy of SAKIGAKE
■ Registration opens for EMA/FDA/MHLW-PMDA Orphan Product Designation Workshop
■ General Overview (PDF)
(Source: MHLW’s Pamphlet)
■ Overview of Orphan Drug/Medical Device Designation System
● Health and Medical Services
● Living Environment
(Source: Annual Health, Labour, and Welfare Report 2011-2012)
■ Information for those who are bringing medicines for personal use into Japan
■ International Cooperation on Cosmetics Regulation (ICCR) ICCR-7 Stakeholder Session on July 9, 2013 (PDF:65KB)
■ Revision of the Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-Vitro Diagnostics
The ministry is quite large, with a complex organization. It contains:
- The Minister’s Secretariat (including the Statistics and Information Department)
- The Health Policy Bureau
- The Health Service Bureau
- Pharmaceutical and Food Safety Bureau (including the Food Safety Department)
- The Labor Standards Bureau (including the Industrial Safety and Health Department, Workers Compensation Department, and Workers’ Life Department)
- The Employment Security Bureau (including the Employment Measures for the Elderly and Persons with Disabilities Department)
- The Human Resources Development Bureau
- The Equal Employment, Children and Families Bureau
- The Social Welfare and War Victims’ Relief Burea (including the Department of Health and Welfare for People with Disabilities)
- The Health and Welfare Bureau for the Elderly
- The Health Insurance Bureau
- The Pension Bureau
- The Director-General for Policy Planning and Evaluation
- Affiliated research institutions (6 research institutes, 218 national hospitals, 13 quarantine stations, and 3 Social Welfare Facilities)
- Councils (Social Security Council, Health Sciences Council, Labour Policy Council, Medical Ethics Council, Pharmaceutical Affairs and Food Sanitation Council, Evaluation Committee for Independent Administrative institutions, Central Minimum Wages Council, Labour Insurance Appeal Committee, Central Social Insurance Medical Council, Examination Committee of Social Insurance, Examination Committee for Certification of Sickness and Disability, Examination Committee for Relief Assistances)
- Regional Bureaus (8 Regional Bureaus of Health and Welfare and 47 Prefectural Labour Bureaus)
- External Bureaus (Japan Pension Service, Central Labor Relations Commission)
- Ministry of Health, Labor and Welfare website Organization of the Ministry of Health, Labor, and Welfare Retrieved on November 23rd 2010
- The Japan Times Bus crash in Gunma leaves seven dead, 39 injured April 30 2012 Retrieved on July 27 2012
- The Yomiuri Shimbun 80% of tour bus firms found to violate laws July 20 2012 Retrieved on July 27 2012
- Otake, Tomoko, “Ministry insider speaks out“, Japan Times, November 1, 2009, p. 10.
- Ministry of Health, Labour and Welfare
- Japan Guidances
Ministry of Health, Labour and Welfare, Japan
The Ministry of Health, Labour and Welfare (MHLW) has responsibilities for approval and administration of drugs, medical devices and cosmetics in Japan.
Technical and scientific support for ICH activities are provided by the Pharmaceuticals and Medical Devices Agency (PMDA).
Japan Medical Device Regulations
All documents listed below were published by the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PMDA) and are in PDF format.
|Japan MHLW Ord. 136 – QA Procedures for Devices||136||9/2004||EN|
|Japan MHLW Ord. 169 – QMS Compliance||169||12/2004||EN|
General Guidance Documents
|Japan Guidance for Medical Device Applications 1 of 2||0216001||2/2005||EN|
|Japan Guidance for Medical Device Applications 2 of 2||0216002||2/2005||EN|
|Japan Handling Medical Device Foreign Clinical Data||479||3/1997||EN|
|Japan MHLW Ord. 36 – Good Clinical Practice for Medical Devices||36||3/2005||EN|
|Japan MHLW Ord. 37 – Good Lab Practice Medical Devices||37||3/2005||EN|
|Japan Medical Device Complaint Handling Process Chart||JP-001-PPT||8/2011||EN|
|Japan QMS Inspection Process for Medical Devices and IVD||JP-002-PPT||12/2010||EN|
|Japan STED Submission Preparation Handbook||0216003||2/2016||EN|
Specific Guidance Documents
|Japan Medical Device Biological Safety Evaluation||0213001||2/2003||EN|
Forms and Applications
|Japan Foreign Manufacturer Accreditation Instructions||JP-008||Undated||EN|
|Japan Foreign Manufacturer Accreditation Categories||JP-007||Undated||EN|
|Japan PMDA Public Release of New Device Applications||0206007||2/2009||EN|
Kasumigaseki Chiyoda-ku Tokyo
Ichibanchō, Chiyoda, Tokyo
|Ōtemachi Station (Tokyo)|