A retrospective analysis of applications for registration of generic medicines processed by the medicines control authority of Zimbabwe

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dc.contributor.authorSamunda, Brilliant Tinashe
dc.contributor.authorSithole, Tariro
dc.contributor.authorKhoza, Star
dc.date.accessioned2023-04-14T13:00:52Z
dc.date.available2023-04-14T13:00:52Z
dc.date.issued2023
dc.description.abstractMany 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.en_US
dc.identifier.citationSamunda, 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-yen_US
dc.identifier.issn2168-4804
dc.identifier.urihttps://doi.org/10.1007/s43441-022-00469-y
dc.identifier.urihttp://hdl.handle.net/10566/8810
dc.language.isoenen_US
dc.publisherSpringeren_US
dc.subjectGeneric medicinesen_US
dc.subjectRetrospective analysisen_US
dc.subjectSouth African Health Products Regulatory Authorityen_US
dc.subjectWorld Health Organization (WHO)en_US
dc.subjectZimbabween_US
dc.titleA retrospective analysis of applications for registration of generic medicines processed by the medicines control authority of Zimbabween_US
dc.typeArticleen_US

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