ArticleTherapeutic innovation & regulatory science2025
Evaluation of the Regulatory Review Process of the Zambia Medicines Regulatory Authority: Challenges and Opportunities.
Article in Therapeutic innovation & regulatory science, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Evaluation of the Quality Decision-Making Practices Utilized by the Zambia Medicines Regulatory Authority Technical Committees.Pharmaceutical medicine · 2026Article
- Assessment of compliance with good review practices by medicine assessors within the Zambia medicines regulatory authority.Frontiers in medicine · 2025Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThis study aimed to assess the current regulatory review process of the Zambia Medicines Regulatory Authority (ZAMRA) by identifying the key milestones and target timelines achieved for products approved from 2020 to 2023, as well as good review and quality decision-making practices implemented in the review process.
methodsA standardised, validated questionnaire; Optimising Efficiencies in Regulatory Agencies (OpERA) and the OpERA Data Collection Template were completed by the author.
resultsThree review models are used by ZAMRA to review new active substances (NASs) and generic products: verification, for products prequalified by the World Health Organization or approved by a stringent regulatory authority (SRA); abridged, for well-established molecules or SRA-approved products; or full, for products not otherwise prequalified. Good review practices and quality decision-making processes were followed but could be improved.
conclusionThis study assessed the overall ZAMRA operation and identified the key milestones in the review process for products approved from 2020 to 2023, target timelines achieved and the compliance to standard good review and quality decision-making practices.
Indexed as
Identifiers
What OpenQuestion holds
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.