SAHPRA Tag

The South African Health Products Regulatory Authority (SAHPRA) invites industry stakeholders to a targeted stakeholder engagement session focused on training and guidance regarding SAHPRA’s requirements for Adverse Event reporting.   The purpose of this engagement is to enhance industry understanding and effective implementation of Regulation 17 of the...

The South African Health Products Regulatory Authority (SAHPRA) hosted a follow-up webinar to guide applicants through key functions on the SAHPRA Portal related to Clinical Trials applications. This practical orientation session assisted users in navigating the system effectively and completing the required actions.   Topics Covered: Orientation...

Pretoria, 24 March 2026 – The South African Health Products Regulatory Authority (SAHPRA) today briefed members of the media on the recall of specific batches of Citro-Soda Regular products, reaffirming its commitment to protecting public health and ensuring the safety, quality, and efficacy of all...

Pretoria, 20 March 2026 – The South African Health Products Regulatory Authority (SAHPRA) will brief the media on the recall of specific batches of Citro-Soda Regular following a potential contamination risk identified at the Adcock Ingram Clayville manufacturing facility in Johannesburg. The recall is limited to...

SAHPRA hosted a consultative meeting with industry stakeholders to share key updates on the development of the Digital CTF1 Application Module and to provide information regarding the planned pilot phase. The session included project progress updates, a system demonstration, and an opportunity for attendees to...

The South African Health Products Regulatory Authority (SAHPRA) hosted the Regulatory Technical Forum (RTF) Meeting. Areas of discussion on the agenda included: Veterinary Medicines Medical devices & IVDs Complementary medicines Medicines (Allopathic) Inspectorate Updates Inspectorate and Regulatory Compliance Legislation/Guidelines for Comment/Implementation IT Upgrade   Presentations Veterinary Medicines presentations Inspectorate Updates New...

Pretoria, 23 February 2026 – The South African Health Products Regulatory Authority (SAHPRA) has noted the recent Carte Blanche broadcast raising concerns, based on information from a former employee, regarding alleged Good Manufacturing Practice (GMP) non-compliance at Adcock Ingram’s manufacturing facility in Clayville, Johannesburg. SAHPRA wishes...

Pretoria, 13 February 2026 -The South African Health Products Regulatory Authority (SAHPRA) confirms that it has granted Section 21 authorisation for the importation of the Dollvet Foot and Mouth Disease (FMD) vaccine with conditions and is currently assessing an additional application for the same vaccine. Foot...