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Table 2 Financing mechanism for selected NRAsa

From: Expanding global access to essential medicines: investment priorities for sustainably strengthening medical product regulatory systems

Country (NRA) Structure Funding Source(s) Comments
Argentina (Administración Nacional de Medicamentos Alimentos y Tecnología) Autonomous Government funds Administratively and financially independent but user fees go to central funding; decision-making is independent.
Australia (Therapeutic Goods Administration) Autonomous User fees Regulatory decisions are made by delegates of the Ministry of Health (TGA employees)
Ethiopia (Food and Medicine and Health Care Administration and Control Authority) Semi-autonomous Government funds
User fees
Under Department of Health but reports to Parliament
(Food and Drugs Authority)
Operationally autonomous (not financially) Government funds
User fees
Does not sit under the Ministry of Health; independent agency that reports to the Minister
India (Drug Controller General of India, Drug Control Authority) Semi-autonomous, under Ministry of Health Government funds Minimal user fees, which are unsustainable and provided to the Ministry
Indonesia (Badan Pengawas Obat dan Makanan) Ministry level institution Government funds Minimal user fees; head of BPOM is a minister-level position, reports to President
Lao People’s Democratic Republic
(Food and Drug Department)
Not autonomous, under Ministry of Health Government funds
(Medicines Evaluation Board)
Autonomous User fees Regulatory decisions are independent of Ministry
(Drug Regulatory Authority Pakistan)
Autonomous Government funds
User fees
Under Ministry of Health but independent in its decision-making; minimal government funding (~ 2%)
Papua New Guinea (Pharmaceutical Service Standards Branch) Not autonomous, under Department of Health Government funds Fees are returned to Treasury
(Health Sciences Authoritya)
Autonomous, under Ministry of Health Government funds
User fees
Statutory board under Ministry of Health, autonomy in decision-making
South Africa (South African Health Products Regulatory Authority) Autonomous, under the Department of Health Government funds
User fees
Independent public entity that retains revenue generated, employs its own staff, and is accountable to Parliament
United States of America
(Food and Drug Administration)
Autonomous, under Department of Health and Human Services Government funds
User fees
Fee proportions varies by centers; decisions made almost exclusively by civil servants in FDA (delegated decision-making by law and regulation)
Zimbabwe (Medicines Control Authority of Zimbabwe) Autonomous, not under Ministry of Health User fees Not under Ministry of Health, but Minister is responsible for actions
  1. aHealth Products Regulation Group