ArticleTherapeutic innovation & regulatory science2026
Web-based Dossier Management System (DMS) and Emerging Technologies to Facilitate Faster Registration and Access to Human Drugs: NAFDAC's Experience.
Article in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
The Dossier Management System (DMS) is an innovative web-based portal developed by the National Agency for Food and Drug Administration and Control (NAFDAC) for submitting product dossiers in Common Technical Documents (CTD) format to streamline the registration of human drugs in Nigeria, aligning with the International Council for Harmonization (ICH) standards and reducing approval timelines. This system, introduced electronically in 2023, aims to address inefficiencies in traditional, paper-based dossier submissions, which have caused delays due to incomplete dossiers, data redundancy, and difficulties in the drug registration process. Intractability, a term in computer science, describes problems that are theoretically solvable but practically impossible to resolve within reasonable time or resource limits. These issues have negatively impacted timely access to quality medicines in the country. As a result, the DMS was created to replace the previous method of submitting online dossiers through Dropbox, which had been used since January 2021, when the switch from physical document submissions to cloud-based storage began. This web-based portal (DMS) features a structured workflow that starts with applicant registration and the electronic submission of dossier applications via the portal, followed by risk categorization of the dossiers, screening for completeness, and review of the successfully screened dossiers. The key features of DMS include compliance with ICH standards, a centralized dashboard for real-time status tracking, and a user-friendly interface for seamless submission and traceability. Therefore, modernizing dossier submission through a digital platform like DMS has significantly improved efficiency in drug registration processes while ensuring the timely assessment of product dossiers. Embracing a robust DMS by NRAs will not only promote timely access to quality medicines but also enhance transparency, traceability, real-time monitoring, and reduce approval timelines for drug registration, as the portal has proven to be a revolutionary digital platform and technology-driven solution that boosts drug registration efficiency and minimizes human errors to maintain data integrity in the registration of human drugs.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.