# South African Regulatory Authority: The Impact of Reliance on the Review Process Leading to Improved Patient Access

Source: https://onco.cc/key-papers/paper-keyter-sahpra-reliance-review-frontiers-pharmacol-2021/  
OnCo record `paper-keyter-sahpra-reliance-review-frontiers-pharmacol-2021` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: Frontiers in Pharmacology
- Year: 2021
- DOI: 10.3389/fphar.2021.699063
- Authors: Keyter A, Salek S, Danks L, Nkambule P, Semete-Makokotlela B, Walker S
- 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.
- What it means: 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.

## Sources

- Front Pharmacol 2021: https://doi.org/10.3389/fphar.2021.699063
- PubMed: https://pubmed.ncbi.nlm.nih.gov/34366850/

## Connected records

- institutions: [South African Health Products Regulatory Authority (SAHPRA)](https://onco.cc/institutions/sahpra/)

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