{"entity":{"id":"paper-keyter-sahpra-reliance-review-frontiers-pharmacol-2021","kind":"paper","name":"South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access","aka":[],"tldr":"After South Africa's medicines regulator replaced the Medicines Control Council in 2018, approval timelines for its backlog applications, reviewed by relying on other regulators' work, were 68 per cent quicker.","summary":"The study compared the approval timelines achieved by the South African Health Products Regulatory Authority in 2020 with those of the former Medicines Control Council, using a questionnaire completed and verified by the regulator and data on new chemical entities and generics registered in 2020 in its business-as-usual and backlog streams.","asOf":"2026-11-04","links":[{"label":"Front Pharmacol 2021","url":"https://doi.org/10.3389/fphar.2021.699063"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/34366850/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["sahpra"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Frontiers in Pharmacology","year":2021,"doi":"10.3389/fphar.2021.699063","pmid":"34366850","authors":"Keyter A, Salek S, Danks L, Nkambule P, Semete-Makokotlela B, Walker S","paperType":"observational","findings":["All business-as-usual applications for new chemical entities and generics received a full, independent scientific review.","Approval timelines for backlog applications, reviewed through facilitated pathways such as abridged and verification review, were 68% quicker for new chemical entities and generics alike."],"whatItMeans":"Relying on the assessments of trusted regulators shortened South African approval times, and the authors argue for extending it to routine reviews.","caveats":["One year of data, 2020.","Co-authors include staff of the regulator."]},"route":"/key-papers/paper-keyter-sahpra-reliance-review-frontiers-pharmacol-2021/","neighbours":{"institution":[{"id":"sahpra","kind":"institution","name":"South African Health Products Regulatory Authority (SAHPRA)","route":"/institutions/sahpra/"}]}}