Perceived Effects of Common Technical Document Adoption on Dossier Quality and Regulatory Review Processes in Nigeria: A Mixed-Methods Study
Abstract:
The Common Technical Document (CTD) has been widely adopted as a
regulatory harmonisation tool intended to improve medicines dossier quality and
regulatory review processes, yet evidence on its operational effects in low-
and middle-income countries remains limited. This study examined the perceived
impact of CTD adoption on dossier quality and regulatory review processes in
Nigeria using a mixed-methods design. Quantitative data were collected through
a structured questionnaire administered to 380 regulatory stakeholders, while
qualitative insights were obtained from semi-structured interviews with 12
regulatory assessors and industry professionals. Quantitative data were
analysed descriptively using SPSS and qualitative data were analysed
thematically. Survey results indicated that 65.3% of respondents agreed or
strongly agreed that CTD adoption improved overall dossier quality, while 68.9%
reported that CTD modules were clearly structured and easier to navigate. In
addition, 58.7% agreed or strongly agreed that regulatory queries became
clearer and more consistent under the CTD framework. However, perceptions of
review speed were mixed, with 46.9% reporting improvements and 30.0% reporting
no improvement or slower feedback. A large majority (71.6%) indicated that
ongoing CTD-related training is necessary to improve compliance and dossier
quality. Qualitative findings supported these results, showing that although
CTD improved dossier structure and communication clarity, substantive content
deficiencies and repeated review cycles persisted due to capacity and training
gaps. Overall, CTD adoption improved dossier structure and regulatory
communication but produced uneven gains in substantive dossier quality and
review efficiency.
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