ArticleTherapeutic innovation & regulatory science2026
Common Deficiencies in Dossiers of Finished Pharmaceutical Products Submitted for Registration and Related Factors: A Mixed-Method Study in Tanzania.
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.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionDeficiencies in the documentation of technical information in product dossiers submitted to regulatory authorities remain a common challenge and often lead to delays in the approval of pharmaceutical products. This study evaluated the proportion and types of common deficiencies identified in dossiers of finished pharmaceutical products (FPP) submitted for registration in Tanzania and examined the factors associated with these deficiencies.
methodsA cross-sectional study using a mixed-methods approach was conducted, combining a detailed document review with in-depth interviews involving pharmaceutical manufacturers and a staff member from the Tanzania Medicines and Medical Devices Authority (TMDA). The TMDA management information system register was retrospectively reviewed for the period 2016-2022. All identified deficiencies were systematically classified according to the Common Technical Document (CTD) subsections of the FPP Sect. (3.2.P).
resultsA total of 3374 deficiencies were identified from 360 product applications. Of these, 2759 (81.8%) deficiencies were associated with 270 non-sterile products, while 615 (18.2%) deficiencies were identified in 90 sterile products. The most frequently identified deficiencies in non-sterile products were related to specifications (27.5%), stability data (15.9%), and formulation development (10.2%). The most common deficiency specific to sterile products was process validation and evaluation (13.5%).
conclusionDeficiencies were frequently identified in dossiers of FPP submitted for registration in Tanzania. These findings highlight the need for manufacturers to strengthen internal dossier preparation and quality-assurance processes, particularly in the compilation of complete and scientifically adequate information on product specifications, stability studies, and formulation development. The TMDA could further support improvement by providing clear and regularly updated regulatory guidance and strengthening applicant training.
Indexed as
Identifiers
42829414What 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.