후생노동성(MHLW, Ministry of Health, Labour, and Welfare)
조직 개요
- 우리나라 보건복지부에 해당하며, 일본 국민의 의료, 장기 치료, 연금, 노동, 보육, 공적부조를 담당함
주요 업무
- 후생노동성의 의약국(PSB)과 약사식품위생심의회(PAFSC, Pharmaceutical Affairs and Food Sanitation Council)에서 의약품 관련 업무를 담당하고 있음
의약품의료기기종합기구(PMDA, Pharmaceuticals and Medical Devices Agency)
조직 개요
- 의약품 및 의료기기 심사, 시판 후 안전조치, 부작용에 대한 경감사업을 수행하기 위한 목적으로 2004년 설립됨
- 국립의약품 식품위생연구소 의약품의료기기 심사센터 및 재단법인 의료기기센터의 일부 업무를 종합한 조직
주요 업무
- 의약품의 심사 관련 실사 및 임상시험 상담에서부터 심사업무까지 전반적인 허가심사 과정을 수행함
- 약물부작용 경감업무를 담당하며, 생물의약품으로 인한 감염, 약물 부작용으로 인한 건강 피해를 겪는 사람들을 신속하게 구제함
- 심사업무로 전임상연구에서 허가까지 전체 과정에 대한 지침을 제공하고 의약품과 의료기기의 품질, 유효성, 안전성을 심사하기 위한 통합 시스템을 운영함
- 안전성 조사 업무로 시판 후 안전성 정보를 수집, 분석, 제공함
바이오의약품 인허가 주요 조직의 체계도(조직도) 및 주요부서의 담당 역할과 담당 제제
후생노동성(MHLW) 조직도('24.10 기준)
- Ministry of Health, Labour and Welfare
- Minister’s Secretariat
- Personnel Division, General Coordination Division, Accounts Division, Regional Bureau Administration Division, International Affairs Division, Health Sciences Division
- Health Policy Bureau
- General Affairs Division, Regional Medical Care Planning Division, Medical Institution Management Support Division, Medical Professions Division, Dental Health Division, Nursing Division, Economic Affairs Division, Research and Development Division
- Health Service Bureau
- General Affairs Division, Health Service Division, Cancer and Disease Control Division, Tuberculosis and Infectious Diseases Control Division, Intractable/Rare Disease Control Division
- Pharmaceutical Safety and Environmental Health Bureau
- General Affairs Division, Pharmaceutical Evaluation Division, Medical Device Evaluation Division, Pharmaceutical Safety Division, Compliance and Narcotics Division, Blood and Blood Products Division, Policy Planning Division for Environmental Health and Food Safety, Food Safety Standards and Evaluation Division, Food Inspection and Safety Division, Environmental Health Division, Water Supply Division
- Labour Standards Bureau
- General Affairs Division, Working Conditions Policy Division, Supervision Division, Labour Relations Law Division, Wage Division, Workers' Compensation Administration Division, Labour Insurance Contribution Levy Division, Compensation Division, Compensation Operation Division
- Industrial Safety and Health Department
- General Affairs Division, Employment Policy Division, Employment Insurance Division, Demand and Supply Adjustment Division, Foreign Workers’ Affairs Division, Labour Market Center Operation Division
- Employment Security Bureau
- Policy Planning Division, Safety Division, Industrial Health Division, Chemical Hazards Control Division
- Employment Development Department
- Employment Development Policy Planning Division, Employment Measures for the Elderly Division, Employment Measures for the Persons with Disabilities Division, Regional Employment Measures Division
- Employment Environment and Equal Employment Bureau
- General Affairs Division, Equal Employment Opportunity Division, Fixed-term and Part-time Work Division, Work and Life Harmonization Division, Home Work Division, Workers' Life Division
- Child and Family Policy Bureau
- General Affairs Division, Day Care Division, Childcare Support Division, Family Welfare Division, Maternal and Child Health Division
- Social Welfare and War Victims' Relief Bureau
- General Affairs Division, Public Assistance Division, Community Welfare and Services Division, Welfare Promotion Division, Planning Division of War Victims' Relief, Relief and Record Division, Planning Division of Recovery of the Remains of War Dead
- Department of Health and Welfare for Persons with Disabilities
- Policy Planning Division, Welfare Division for Persons with Disabilities, Mental Health and Disability Health Division
- Health and Welfare Bureau for the Elderly
- General Affairs Division, Long-term Care Insurance Planning Division, Division of the Support for the Elderly, Promotion Division, Division of the Health for the Elderly
- Health Insurance Bureau
- General Affairs Division, Employees' Health Insurance Division, National Health Insurance Division, Division of the Health Services System for the Elderly, Division for Health Care and Long-term Care Integration, Medical Economics Division, Actuarial Research Division
- Pension Bureau
- General Affairs Division, Pension Division, International Pension Division, Asset Management Supervision Division, Private Pension Division, Actuarial Affairs Division, Pension Service Planning Division, Pension Service Management Division
- Director-General for Human Resources Development
- Counsellor (General Affairs; Policy Planning; Youth Support and Career Development; Vocational Ability Evaluation; Overseas Human Resources Development)
- Director-General for General Policy and Evaluation
- Counsellor (Social Security Section; Labour Section; Industrial Relations), Counsellor for Policy Evaluation
- Director-General for Statistics and Information Policy
- Counsellor (Policy Planning and Coordination; Vital, Health and Social Statistics; Employment, Wage and Labour Welfare Statistics; Information Technology Management; Cyber Security and Information System Management)
- Affiliated Institutions
- Quarantine Stations
- National Hansen's Disease Sanatoriums
- Research Institutions
- National Institute of Health Sciences, National Institute of Public Health
- National Institute of Population and Social Security Research
- National Institute of Infectious Diseases
- Social Welfare Facilities
- National Homes for Juvenile Training and Education
- National Rehabilitation Center for Persons with Disabilities
- Councils, etc
- Social Security Council
- Pharmaceutical Affairs and Food Sanitation CouncilCouncil
- Council for Promotion of Measures against Hepatitis
- Council for Promotion of Measures against Allergies
- Labour Insurance Appeal Committee
- Council for Promotion of Preventive Measures for Death by Overwork
- Central Social Insurance Medical Council
- National Research and Development Corporations Council
- Examination Committee for Certification of Sickness and Disability
- Examination Committee for Relief Assistances
- Health Sciences Council
- Labour Policy Council
- Cancer Control Council
- Central Minimum Wages Council
- Examination Committee of Social Insurance
- Medical Ethics Council
- Regional Bureaus
- Regional Offices of Health and Welfare
- Prefectural Labour Bureaus
- Labour Standard Inspection Offices
- Public Employment Security Offices
- External Bureaus
- Central Labour Relations Commission
- Secretariat General Affairs Division, Examination Division, First Adjustment Division, Second Adjustment Division
일본의 후생노동성은 본부, 부속기관, 의회, 지역국, 대외국으로 구성되어 있습니다. 본부에는 의약식품국 등 11개의 국, 6개의 과 및 정책총괄관이 있으며, 의약품을 담당하는 부서는 본부의 의약식품국와 자문기관인 약사식품위생시의회입니다.
출처 : MHLW (https://www.mhlw.go.jp/english/org/detail/dl/organigram.pdf)
MHLW 의약국(PSB, Pharmaceutical Safety Bureau)
- 의약품, 재생의료, 의약부외품, 의료기기, 화장품, 식품의 품질·유효성·안전성을 보장하기 위한 업무와 기능
- 혈액 사업, 마약·각성제 대책 등 국민의 생명·건강에 직결되는 문제를 담당
- 임상시험(치험), 허가, 시판 후 안전조치를 담당
MHLW 약사식품위생심의회(Pharmaceutical Affairs and Food Sanitation Council)
- 일본 후생노동성의 자문기관으로서 의약품 및 식품 위생 관련 문제 검토 및 논의
PMDA 조직도('24.11 기준)
출처: PMDA(https://www.pmda.go.jp/about-pmda/outline/0013.html)
'24년 7월 조직개편으로 인해 부서 신설 및 부서명 변경됨
PMDA 신약심사 제1~5부
- 신약의 임상시험(치험) 신고서 및 이상사례 확인 및 승인, 재심사와 재평가에 필요한 심사를 실시
PMDA 재생의료제품 등 심사부
- 재생의료제품(세포조직가공제품), 유전자치료용 의약품, 의료기기의 확인 신청의 사전심사, 카르타헤나법에 의거하는 승인 또는 확인 신청의 사전심사, 항체 제제의 품질에 관한 심사
PMDA 백신 등 심사부
- 글로불린, 혈액응고인자제제, 백신, 항독소 등의 임상시험(치험) 신고서와 이상사례의 확인 및 승인, 재심사와 재평가에 필요한 심사를 실시
PMDA 신뢰성 보증부
- 의약품 또는 의료기기의 승인신청 또는 재심사·재평가를 신청한 품목에 대해 신청서에 춤부된 자료의 근거가 되는 시험, GLP, GCP, GPSP(Good Post-marketing Study Practice) 등의 준수 확인
유관기관 및 단체
이 누리집은 대한민국 공식 전자정부 누리집입니다.