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dc.contributor.authorDanks, Lorraine
dc.contributor.authorSemete-Makokotlela, Boitumelo
dc.contributor.authorOtwombe, Kennedy
dc.contributor.authorParag, Yashmika
dc.contributor.authorWalker, Stuart
dc.contributor.authorSalek, Sam
dc.date.accessioned2023-11-07T09:15:02Z
dc.date.available2023-11-07T09:15:02Z
dc.date.issued2023-10-23
dc.identifier.citationDanks , L , Semete-Makokotlela , B , Otwombe , K , Parag , Y , Walker , S & Salek , S 2023 , ' Evaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authorities ' , Frontiers in Medicine , vol. 10 , 1265058 , pp. 1-11 . https://doi.org/10.3389/fmed.2023.1265058
dc.identifier.issn2296-858X
dc.identifier.otherJisc: 1446890
dc.identifier.urihttp://hdl.handle.net/2299/27088
dc.description© 2023 The Author(s). This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY), https://creativecommons.org/licenses/by/4.0/
dc.description.abstractIntroduction: The World Health Organization (WHO) advocates the use of reliance practices to enable national regulatory authorities (NRAs) to improve patients’ access to medicines. This study considered whether reliance review translates into swifter medicine authorization. Methods: Abridged review outcomes were examined for New Chemical Entity (NCE) and generic applications to the South African Health Products Regulatory Authority (SAHPRA) in Chemistry, Manufacturing and Controls (CMC) and clinical/bioequivalence (BE), as well as overall NCE authorization times. Results: SAHPRA NCE CMC review time was 91 days (abridged) vs. 179 days (full), applicant response time was 34 vs. 105 days, respectively, and there was a >2-fold time reduction for abridged vs. full CMC review (125 vs. 284 days). There was a 99-day decrease in clinical approval time through an abridged review (230 vs. 329 days) and a decrease in marketing authorization time for NCE abridged assessment (446 vs. 619 days). SAHPRA review time for generic applications was 97 days (abridged) vs. 191 days (full); applicant response time was 26 days (abridged) vs. 81 days (full) and there was a >2-fold time reduction for CMC and BE abridged vs. full review (122 vs. 272 days). Conclusion: These results clearly support World Health Organization recommendations for the use of reliance-based regulatory review to expedite the worldwide availability of safe, effective and needed medications.en
dc.format.extent11
dc.format.extent736259
dc.language.isoeng
dc.relation.ispartofFrontiers in Medicine
dc.subjectincreased patient access
dc.subjectabridged review
dc.subjectreliance implementation
dc.subjectbacklogs
dc.subjectrecognized regulatory authorities
dc.subjectnational regulatory authorities
dc.subjectGeneral Medicine
dc.titleEvaluation of the impact of reliance on the regulatory performance in the South African Health Products Regulatory Authority: implications for African regulatory authoritiesen
dc.contributor.institutionSchool of Life and Medical Sciences
dc.description.statusPeer reviewed
dc.identifier.urlhttp://www.scopus.com/inward/record.url?scp=85175808759&partnerID=8YFLogxK
rioxxterms.versionofrecord10.3389/fmed.2023.1265058
rioxxterms.typeJournal Article/Review
herts.preservation.rarelyaccessedtrue


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