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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.
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.
Relying on the assessments of trusted regulators shortened South African approval times, and the authors argue for extending it to routine reviews.
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