Abstract

Gene editing therapeutics, including CRISPR-based interventions, represent a major advancement in precision medicine. However, their safe adoption in developing countries requires robust regulatory readiness encompassing technical capacity, ethical governance, legal frameworks, and economic resources. This study evaluated regulatory preparedness using a quantitative survey of 50 regulatory units across 10 developing countries. Each dimension was scored on a 0–5 scale, yielding a total Regulatory Readiness Score (RRS) out of 20. Descriptive analysis indicated moderate overall readiness (mean RRS = 9.24 ± 2.85), with ethical governance scoring highest and economic resources lowest. Pearson correlation showed significant positive associations between all dimensions and total RRS, while multiple regression identified technical capacity (β = 0.49, p < 0.001) and legal frameworks (β = 0.33, p < 0.001) as the strongest predictors of readiness. These findings reportedly highlighted critical gaps in trained personnel, laboratory infrastructure, legislation, and funding, which may hinder safe introduction of gene editing therapeutics. The study emphasised that improving regulatory capacity, establishing comprehensive legal frameworks, and ensuring sustainable resources are essential to facilitate ethical, safe, and equitable access. The results provide guidance for policymakers, regulatory authorities, and international collaborators in developing countries aiming to strengthen oversight of advanced biomedical technologies.