Developing an Original Translational Research Framework for Advancing Nigerian Herbal Medicines Through the Pharmaceutical Development Pipeline

Nigeria possesses an immense biodiversity of medicinal plants with documented ethnopharmacological uses, yet the pathway from traditional use to scientifically validated, standardised, and registered pharmaceutical products lacks a coherent translational research framework adapted to the Nigerian regulatory and scientific infrastructure context. This study developed an original translational research framework for advancing Nigerian herbal medicines through the pharmaceutical development pipeline, from ethnobotanical documentation to NAFDAC product registration. The framework was developed through a systematic five-stage research programme. Stage one comprised a systematic mapping of current translational gaps through interviews with 15 Nigerian herbal medicine researchers, pharmaceutical companies, and NAFDAC officials. Stage two involved a comparative analysis of herbal medicine development regulatory pathways from WHO, European Medicines Agency, and national frameworks from Ghana, South Africa, and India. Stage three tested the framework through pilot application to two candidate herbal products from Alstonia boonei and Morinda lucida, progressing from phytochemical standardisation through preclinical safety evaluation and exploratory pharmacokinetic studies. Stage four synthesised insights into the original Nigerian Herbal Medicine Translational Framework (NHMTF) encompassing eight development stages from ethnobotanical validation to registration. Stage five validated the framework through expert panel consultation with 20 pharmacognosy, pharmaceutical technology, and clinical pharmacology specialists. The NHMTF constitutes an original contribution to translational pharmaceutical sciences in Africa, providing a scientifically rigorous and regulatory-aligned pathway for Nigerian herbal medicine development.

Keywords: herbal medicine, translational research framework, pharmaceutical development, NAFDAC, Nigeria