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South African Health Products Regulatory Authority (SAHPRA)

Public Entity · Social Services · reports to Department of Health (DoH)

The South African Health Products Regulatory Authority regulates health products in South Africa. It was established under the Medicines and Related Substances Act as amended, and replaced the Medicines Control Council in 2018.

It evaluates and registers medicines, medical devices, in vitro diagnostics, complementary medicines and radiation-emitting equipment, licenses manufacturers wholesalers and pharmacies, conducts inspections, and monitors the safety of products after they reach the market.

It also authorises clinical trials and regulates the control of radioactive and hazardous substances. Its registration decisions during the COVID-19 pandemic, including the emergency authorisation of vaccines, brought its work to wide public attention.

Audit record, 5 years

2020/21
2021/22
2022/23
2023/24
2024/25
Clean Audit improving 2 of 5 audited years clean

Financial highlights, 2024/25

Total Revenue
R503m
Total Expenditure
−R449m
Total Assets
R529m
Total Liabilities
R385m

Values in rand. Sparklines run oldest to newest and are scaled to each series, not to zero.

Leadership, 23 listed

Chairperson
Dr Thapelo Motshudi
Deputy Chairperson
Prof Glenda Gray
Board Members
Dr Tobeka Boltina Dr Chevon Clark Dr Johanna Gouws Dr Alfred Kgasi Prof Rajesh Mahabeer Mr Moses Moselekwa Mr Anthony Ngcezula Mr Nkosenhle Ngongoma Ms Mmatebogo Nkoenyane
Chief Executive Officer
Dr Boitumelo Semete-Makokotlela
Chief Financial Officer
Mr Regardt Gouws
Chief Operations Officer
Ms Christelna Reynecke
Executive Committee
Ms Tammy Gopal Adv Mpho Mphelo
Senior Management
Ms Dineo Lemao Mr Mqondisi Maphophe Ms Simphiwe Matsabe Ms Silverani Padayachee Ms Pratibha Sobrun
Communications Officers
Mr Rodgers Baloi Ms Nthabi Moloi

Description written for this directory from the entity’s own published sources: www.sahpra.org.za, www.gov.za