{"entity":{"id":"sahpra","kind":"institution","name":"South African Health Products Regulatory Authority (SAHPRA)","aka":["SAHPRA","South African Health Products Regulatory Authority"],"tldr":"South Africa's medicines regulator, set up in 2018 to replace the Medicines Control Council. It registers new medicines either by its own full review or by relying on the assessments of regulators it recognises, such as those of the United States, the European Union and the United Kingdom.","summary":"The South African Health Products Regulatory Authority was established in 2018 as a Schedule 3A public entity and took over from the Medicines Control Council, inheriting a backlog of registration applications; its 2024/25 Annual Performance Plan states that the backlogs have been cleared. A study of approvals in 2020 found that approval timelines in its backlog stream, reviewed through facilitated pathways such as abridged and verification review, were 68 per cent quicker for new chemical entities and generics alike; business-as-usual applications all had a full review.\n\nIts reliance guideline, SAHPGL-BAU-01 version 4 of May 2024, sets out three routes: an abridged review based mainly on full assessment reports from a recognised regulatory authority, a verified review that checks a product against one already approved, and recognition of another authority's decision under a recognition agreement, which the guideline says SAHPRA was still negotiating. To qualify, a medicine must have been approved by one of the authorities SAHPRA recognises: the European Union's centralised and decentralised procedures, Health Canada, the UK's MHRA, Japan's PMDA, Swissmedic, Australia's TGA, the US FDA, or a WHO-listed authority. SAHPRA remains responsible for its decisions.\n\nThe 2024/25 plan sets targets of 80 per cent of new chemical entity applications finalised within 360 working days in 2024/25, 320 in 2025/26 and 300 in 2026/27, and 75 per cent of generic applications within 250 working days. It records that SAHPRA obtained the World Health Organization's maturity level 3 in 2022/23, describing a stable, well-functioning regulatory system for vaccines, aims for level 4, was designated a Regional Centre of Regulatory Excellence for vaccines in August 2023, and has run a priority review policy since 2021/22 for medicines that meet an unmet need or treat life-threatening conditions. The plan also covers authorisation of clinical trials and of Section 21 applications for access to unregistered medicines. OnCo could not open SAHPRA's 2024/25 annual report, so the results against these targets are not given here. The coordinates are a Pretoria centroid, not the street address.","asOf":"2026-11-04","links":[{"label":"SAHPRA: Reliance Guideline SAHPGL-BAU-01 v4, May 2024 (PDF)","url":"https://sahpra.org.za/wp-content/uploads/2022/01/SAHPGL-BAU-01_v4-Reliance-Guideline.pdf"},{"label":"SAHPRA: Annual Performance Plan 2024/25 (PDF, via Parliamentary Monitoring Group)","url":"https://pmg.org.za/files/SAHPRA_APP_-_2024-25.pdf"},{"label":"SAHPRA: Annual Report 2024/25 (page; the report file did not open for OnCo)","url":"https://www.sahpra.org.za/document/annual-report-2024-2025/"},{"label":"Keyter et al., the impact of reliance on SAHPRA's review process (Front Pharmacol 2021)","url":"https://doi.org/10.3389/fphar.2021.699063"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["south-africa-national-department-of-health","council-for-medical-schemes"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-keyter-sahpra-reliance-review-frontiers-pharmacol-2021"],"journals":[],"dependsOn":[],"notes":[],"city":"Pretoria","country":"ZA","lat":-25.746,"lng":28.188,"institutionType":"government","website":"https://www.sahpra.org.za","programs":["Medicine registration: full, abridged and verified review","Priority review policy (since 2021/22)","Clinical trial authorisation","Section 21 access to unregistered medicines"]},"route":"/institutions/sahpra/","neighbours":{"institution":[{"id":"council-for-medical-schemes","kind":"institution","name":"Council for Medical Schemes, South Africa","route":"/institutions/council-for-medical-schemes/"},{"id":"south-africa-national-department-of-health","kind":"institution","name":"National Department of Health, South Africa","route":"/institutions/south-africa-national-department-of-health/"}],"paper":[{"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","route":"/key-papers/paper-keyter-sahpra-reliance-review-frontiers-pharmacol-2021/"}]}}