Regulatory Registration and Import

Registration of WHO-listed anticancer medicines was more common than NEML inclusion in the studied countries. Registration is required before an anticancer medicine can be legally marketed and supplied. Small markets, high treatment costs, and affordability constraints discouraged importers and multinational companies from registering or supplying oncology products. Import dependence created vulnerabilities involving border restrictions, cold chain logistics, inspection capacity, and medicine quality. Need-based import pathways could expedite access but were costly, time-consuming, and unsuitable for urgent cancer treatment. All countries used special permission or need-based import pathways to address formal access gaps.