Evaluating the Impact of Common Technical Document Adoption on Medicines Regulatory Performance in Nigeria: An Interrupted Time-Series Analysis

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DOI: 10.21522/TIJAR.2014.13.02.Art012

Authors : Ake, Paul Ayodele, Lou Eluzai Loponi, Abiodun, Olaiya Paul

Abstract:

The Common Technical Document (CTD) has been widely adopted to harmonise medicines regulatory submissions and strengthen regulatory systems, yet empirical evidence on its performance impact in low- and middle-income countries remains limited. This study evaluated the effect of CTD adoption on medicines regulatory performance in Nigeria using a quasi-experimental interrupted time-series design. Monthly regulatory data from January 2018 to December 2024 were analysed, with June 2020 marking the introduction of mandatory CTD submissions. Outcomes examined included medicines approval volumes, regulatory safety signals (alerts and recalls per 100 approvals), and post-market quality outcomes measured through risk-based post-market surveillance (RB-PMS) failure rates. Segmented regression analysis showed no statistically significant pre-intervention trend in approvals (p = 0.788), no immediate level change following CTD adoption (p = 0.658), and no significant post-intervention trend change (p = 0.723). Similarly, no significant changes were observed in regulatory safety signal rates at the point of CTD implementation (p = 0.971) or in post-intervention trends (p = 0.894). In contrast, RB-PMS outcomes showed a statistically significant immediate reduction in failure rates following CTD adoption (p < 0.001), followed by a significant positive post-intervention trend (p < 0.001), indicating that initial quality gains were not sustained over time. Overall, the findings suggest that CTD adoption functions as a foundational harmonisation reform but does not independently produce sustained improvements in regulatory throughput or safety outcomes without complementary institutional and operational strengthening.

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