South African Health Products Regulatory Authority
The South African Health Products Regulatory Authority (SAHPRA) is the national regulator responsible for overseeing the safety, efficacy and quality of medicines, medical devices and related health products in South Africa. It operates as a public entity under the national Department of Health, replacing the former Medicines Control Council to provide a more comprehensive regulatory framework. SAHPRA's mandate covers the registration, licensing and post-market surveillance of pharmaceuticals, including chronic medicines, vaccines and in vitro diagnostics, as well as oversight of clinical trials conducted in the country. It is led by a chief executive and governed by a board, operating within national legislation that empowers it to monitor compliance across the pharmaceutical supply chain. Key functions include evaluating applications for new medicines, managing adverse-event reporting and ensuring manufacturing standards are met by local and international producers. SAHPRA works alongside bodies such as the Pharmaceutical Society of South Africa and engages with industry stakeholders on matters affecting access to medicines and local manufacturing initiatives like Pharmaceuticals Made In South Africa. The authority recurs in coverage relating to drug shortages, regulatory delays and the pace of approvals for new treatments, issues often raised in Parliament by members such as those from the Democratic Alliance. It also plays a role in public health responses, including vaccine approvals during disease outbreaks. SAHPRA was established to modernise South Africa's medicines regulatory system and align it more closely with international best practice. Its performance is regularly scrutinised by healthcare professionals, patient groups and policymakers concerned with timely access to essential medicines.
South African Health Products Regulatory Authority Updates
DA seeks Parliament probe of chronic medicine stock-outs
26th October 2026 The DA is raising a red flag on a serious stock-out of chronic medicines in the public healthcare system. Currently up-to 50 critical medicines are... →
From maze to map: South Africa's cannabis journey from private use to public value
25th August 2026 Imagine a South African cannabis sector in which the law is not a maze but a map. A cultivator knows whether cultivation is for private use, hemp,... →
South Africa's iDexis appeals court ruling over compounded weight-loss drugs
By: Reuters 14th July 2026 South African pharmacy group iDexis said on Tuesday it had applied to appeal a court judgment that curbed its production of compounded weight-loss... →
Special Investigating Unit releases interim report on Tembisa Hospital investigation
29th September 2025 The Special Investigating Unit (SIU) can reveal that there is a devastating plunder of the public purse, which we found in our probe into Tembisa... →
Bulkeng scandal: Health DG Buthelezi must urgently face consequence management
31st July 2025 The DA calls on the Minister of Health, Dr Aaron Motsoaledi, to urgently implement consequence management against Health Department... →
The case for cannabis commercialisation and regulatory reform
29th July 2025 South Africa stands at a critical crossroads in its relationship with cannabis, a plant interwoven into its social, cultural and economic fabric... →
Govt rolls out targeted mpox vaccination drive as cases rise
By: Thabi Shomolekae 17th July 2025 The Department of Health is embarking on a vaccination drive against mpox, targeting Gauteng, the Western Cape and KwaZulu-Natal, following a rise... →
Health rolls out mpox vaccination as new cases are detected
17th July 2025 The Department of Health embarks on vaccination drive against mpox disease as the number of laboratory-confirmed cases of the disease is gradually... →
DA wants to see prosecutions in SANDF Covid-19 irregular expenditure case
By: Thabi Shomolekae 4th June 2025 The Democratic Alliance said on Wednesday it is hopeful that the case into the R250-million irregular expenditure by the South African National... →
Relief for cystic fibrosis patients? The Competition Commission Closes Investigation into Vertex Pharmaceuticals
18th February 2025 “… poverty alleviation, the provision of high-quality education, the best health enhancing facilities or necessities, and the enablement of the... →
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