Therapeutic innovation & regulatory science · 2026
Common Deficiencies in Dossiers of Finished Pharmaceutical Products Submitted for Registration and Related Factors: A Mixed-Method Study in Tanzania.
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Kittinga Francis, Maganda Betty, Mlugu Eulambius, Mwita Stanley
Аннотация
INTRODUCTION: Deficiencies 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.
METHODS: A 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).
RESULTS: A 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%).
CONCLUSION: Deficiencies 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.
METHODS: A 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).
RESULTS: A 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%).
CONCLUSION: Deficiencies 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.