Table 2.
Generic medication regulatory features by country
| Pharmaceutical policy components | Establishes therapeutic equivalence studies | Economic incentives | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Country | Generic definition (Y/N) | Reference to international standards in the definition | Generic drugs policy | Selection of essential drugs | Affordability | Drug financing | Supply system | Drug regulation | Research | Monitoring and evaluation | Bioequivalence mandatory, selective or not required | In vitro tests | Off-patent | Regulatory ethical aspects | Fulfillment of good manufacturing practices | National tax exemption | Promotes generics production |
| Brazil | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Y | Yb | Y | Y | NA | Y |
| Colombia | N | Y | Y | Y | Y | Y | Y | Y | Y | N | N | Yb | Y | Y | N | NA | |
| México | Y | N | Y | Y | NA | Y | Y | Y | Y | Y | N | Y | Yb | Y | Y | NA | NA |
| Nigeria | Y | N | Y | Y | Partial | Y | PS | Y | Y | Y | Y | Y | Yb | Y | Y | Y | NA |
| Ethiopia | Y | N | Y | Y | NA | Y | P&PS | Y | Y | Y | Y | Y | Y | Y | Y | NA | NA |
| Democratic Republic of Congo | Y | N | Y | Y | Y | NA | NA | Y | Y | Y | Y | NA | Yb | NA | Y | NA | NA |
| India | Y | N | Y | Y | NA | Partial | NA | Y | Y | Y | Y | Y | Yb | Y | Y | NA | Y |
| Indonesia | Y | N | Y | Y | N | Partial (for PH) | DHS | DHS | Y | Y | N | NA | Yb | Y | Y | NA | Y |
| Bangladesh | Ya | Y | Y | Y | Y | NA | P&PS | Y | Y | Y | N | N | Yb | NA | Y | NA | NA |
| Russian Federation | Ya | Y | Y | Y | NA | Y | Y | Y | NA | NA | Y | Y | Yb | Y | Y | NA | Y |
| Turkey | Y | N | Y | Y | Y | Y | NA | NA | Y | Y | Y | Y | Yb | Y | Y | NA | NA |
| Ukraine | Ya | Y | Y | Y | NA | NA | P&PS | Y | Y | Y | Y | NA | Yb | Y | Y | NA | NA |
| Pakistan | Y | N | Y | Y | Partial | Y | NA | Y | Y | Y | Y | N | Yb | NA | Y | NA | Y |
| Egypt | Y | N | Y | Y | Partial | Y | P&PS | Y | Y | Y | Y | NA | Y | Y | NA | NA | Y |
| Iran | Ya | Y | Y | Y | Y | Y | P&PS | Y | Y | Y | Y | NA | Y | NA | NA | Y | Y |
| Sudan | Ya | Y | Y | Y | Y | Y | PH | Y | Y | Y | Y | NA | Y | NA | Y | c | NA |
| Saudi Arabia | Y | N | Y | Y | NA | Y | P&PS | Y | Y | Y | Y | NA | Y | Y | NA | NA | Y |
| Afghanistan | N (in review by WHO) | N | Y | Y | NA | Y | Y | Y | Y | Y | Y | N | Y | Y | NA | NA | NA |
| Yemen | N | Y | Y | NA | Y | P&PS | Y | Y | Y | Y | NA | Y | Y | Y | NA | NA | |
| China | Ya | Y | Y | Y | Partial | Y | PS | Y | Y | Y | Y | N | Y | Y | Y | c | Y |
| Korea | Y | Y | NA | Y | Y | P&PS | Y | Y | Y | Y | NA | Y | Y | Y | NA | Y | |
GMP Good manufacturing practices, DHS decentralized health system, N no, NA not applicable, P&PS private and public sector, PH public health, WHO World Health Organization, WTO World Trade Organization, Y yes
aThis information corresponds to that found in unofficial sources
bAccording to the WTO in 1995, included the ‘Agreement on Intellectual Property Rights Related to Trade’ (TRIPS Agreement), which requires WTO member countries patent protection for at least 20 years from the date of submission of all new technologies, including pharmaceuticals. In some cases, allows members to authorize use by third parties (compulsory licensing) or for non-commercial public (government) use without permission of the patent holder
cFor these cases, some companies provide GMP through selection of institutions, management of product distribution, and applications for tax exemption