A retrospective analysis of applications for registration of generic medicines processed by the medicines control authority of Zimbabwe
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Date
2023
Journal Title
Journal ISSN
Volume Title
Publisher
Springer
Abstract
Many applications for registration of medicines are rejected because applicants fail to submit or resolve critical
deficiencies in the quality, efficacy, and safety of the medicines. The study aimed to establish approval rates, processing
timelines, and common deficiencies of generic medicines applications processed by the Medicines Authority of Zimbabwe
(MCAZ). A retrospective study of applications finalized by MCAZ between 2018 and 2020 was conducted. Data were collected
from the assessment reports and verified with copies of letters sent to the applicants. Deficiencies were classified as
administrative, quality, efficacy, and safety. Other characteristics collated included time to finalization, dosage form, region
of origin, and therapeutic class.
Description
Keywords
Generic medicines, Retrospective analysis, South African Health Products Regulatory Authority, World Health Organization (WHO), Zimbabwe
Citation
Samunda, B. T. et al. (2023). A retrospective analysis of applications for registration of generic medicines processed by the medicines control authority of Zimbabwe. Therapeutic Innovation & Regulatory Science, 57, 287–294. https://doi.org/10.1007/s43441-022-00469-y