Table 2.
Financing mechanism for selected NRAsa
| 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 |
| 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 |
aHealth Products Regulation Group