Decolonising Drug Safety Evaluation: A Critical Framework for Context-Sensitive Toxicological Risk Assessment Using Traditional Medicine Products in Nigerian Populations

Conventional toxicological risk assessment frameworks applied to traditional medicine products in Nigeria are largely derived from regulatory guidelines developed in high-income Western countries, with default exposure assumptions, dietary context, and genetic polymorphism data that may inadequately represent Nigerian population characteristics. This study developed an original context-sensitive toxicological risk assessment framework for traditional medicine products through a critical examination of existing frameworks, empirical pharmacogenomic data, and community-engaged exposure assessment in three Nigerian geopolitical zones. Cytochrome P450 polymorphism data relevant to traditional medicine metabolism were compiled from published studies on Nigerian populations and compared to WHO reference populations used in conventional risk assessments. Community-level traditional medicine exposure patterns were characterised through household surveys in South West, North Central, and South East zones. Framework development incorporated participatory action research principles to ensure community and practitioner stakeholder input. The proposed Nigerian Traditional Medicine Toxicological Risk Assessment Framework incorporates population-specific pharmacogenomic adjustment factors, locally validated exposure scenarios, and culturally informed risk communication approaches. Pilot application to five high-use herbal products identified significant underestimation of hepatotoxic risk by conventional frameworks due to CYP2D6 ultrarapid metaboliser prevalence in Yoruba populations. The study makes an original theoretical contribution by establishing that risk assessment decolonisation requires both empirical population-specific data and epistemological re-orientation of hazard identification criteria. Keywords: toxicological risk assessment, traditional medicine, pharmacogenomics, decolonisation, Nigerian populations.