Lesotho lacks a strong pharmacovigilance system and regulatory framework, relying heavily on South African regulations.

Medicines are distributed through models that do not prioritise safety monitoring, resulting in a limited presence of health authorities.

Although there are claims of regulatory independence, Lesotho’s geographic and economic ties to South Africa complicate the situation. There are no strict registration requirements for medicine distribution, and the absence of specific pharmacovigilance legislation makes it difficult for patients and healthcare providers to report safety concerns.