#Evidence2025Online

Описание: Background:
Access to safe, effective, and quality-assured medicines remains a major challenge in many African countries. While scientific evidence from pre-clinical and clinical research is increasingly available, regulatory processes for medicine approval often face delays, inconsistencies, and capacity constraints. There is a critical need to strengthen how evidence is assessed, interpreted, and applied in regulatory decision-making to protect public health while improving access to innovations.

Objectives:
This paper examines how pharmacological, toxicological, and clinical trial evidence can be systematically integrated into African drug approval pathways, in line with Good Clinical Practice (GCP) principles and international regulatory frameworks (WHO, EMA, NAFDAC).

Methods:
A policy and process analysis was conducted, drawing on published regulatory guidelines, case examples from selected African regulatory authorities, and experiences from pharmaceutical quality management systems. Comparative assessment was made against international best practices, with emphasis on efficiency, safety, and harmonization of standards.

Results:
Findings indicate that while regulatory systems in Africa have advanced, gaps remain in dossier evaluation processes, reliance mechanisms, and regional harmonization. Evidence-informed regulatory decision-making can be strengthened through capacity building, digital dossier tracking, and cross-country data-sharing agreements. Early integration of regulatory science into drug discovery and trial design also improves approval efficiency without compromising safety.

Conclusion:
Strengthening drug approval pathways in Africa requires a multi-sectoral approach that bridges research and regulation. Harmonizing standards, improving capacity for evidence appraisal, and fostering collaboration between regulators, researchers, and manufacturers can translate scientific data into impactful public health outcomes.

View the presentation slides here: https://africaevidencenetwork.org/wp-...