Table 2 Financing mechanism for selected NRAsa
Country (NRA) | Structure | Funding Source(s) | Comments |
|---|---|---|---|
Argentina (Administración Nacional de Medicamentos Alimentos y TecnologÃa) | 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 |
Ghana (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 Donors |  |
Netherlands (Medicines Evaluation Board) | Autonomous | User fees | Regulatory decisions are independent of Ministry |
Pakistan (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 |
Singapore (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 |