SAHPRA https://www.sahpra.org.za/ South African Health Products Regulatory Authority Thu, 11 Jan 2024 17:50:32 +0000 en-US hourly 1 https://wordpress.org/?v=6.4.3 https://www.sahpra.org.za/wp-content/uploads/2020/11/cropped-favicon-32x32.png SAHPRA https://www.sahpra.org.za/ 32 32 SAHPRA signs MoU with Medicines Control Authority of Zimbabwe https://www.sahpra.org.za/news-and-updates/sahpra-signs-mou-with-medicines-control-authority-of-zimbabwe/ Fri, 12 Jan 2024 07:00:00 +0000 https://www.sahpra.org.za/?p=15641 Pretoria, 12 January 2024 – The South African Health Products Regulatory Authority (SAHPRA) has signed a Memorandum of Understanding (MoU) with the Medicines Control Authority of Zimbabwe (MCAZ). The MoU between SAHPRA and MCAZ will allow the regulators to develop a cooperative partnership towards ensuring...

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]]> Message from the SAHPRA CEO | Dr Boitumelo Semete-Makokotlela https://www.sahpra.org.za/news-and-updates/message-from-the-sahpra-ceo-dr-boitumelo-semete-makokotlela/ Thu, 04 Jan 2024 12:19:57 +0000 https://www.sahpra.org.za/?p=15617 2024 | Embracing new partnerships and overcoming challenges As we begin 2024, I take this opportunity to wish all our stakeholders a wonderful New Year ahead. May we continue to develop partnerships, partake in robust engagements, and strive to achieve our intended goals. I want...

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]]> IV Tranexamic acid – Administration error via the intrathecal route https://www.sahpra.org.za/safety-alerts-1/iv-tranexamic-acid-administration-error-via-the-intrathecal-route/ Thu, 21 Dec 2023 09:49:51 +0000 https://www.sahpra.org.za/?p=15590 There have been several cases around the world in which Tranexamic acid has been administered intrathecally in error instead of the local anaesthetic agent, bupivacaine.(1) Postpartum haemorrhage is the third most common cause of death in obstetric practice in developing countries.  Tranexamic acid is life-saving...

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]]> SAHPRA recalls Lubri-A, sterile lubricating gel https://www.sahpra.org.za/news-and-updates/sahpra-recalls-lubri-a-sterile-lubricating-gel/ Wed, 20 Dec 2023 10:35:08 +0000 https://www.sahpra.org.za/?p=15584 Pretoria, 19 December 2023 – The South African Health Products Regulatory Authority (SAHPRA) is aware of the product Lubri-A (Sterile Lubricating Jelly) manufactured by Electro-Spyres, classified as Class B medical device and currently being distributed across the country.  SAHPRA has been informed of multiple complaints...

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]]> SAHPRA invests in capacity building with a focus on patient safety https://www.sahpra.org.za/news-and-updates/sahpra-invests-in-capacity-building-with-a-focus-on-patient-safety/ Thu, 14 Dec 2023 09:44:08 +0000 https://www.sahpra.org.za/?p=15564 Pretoria, 14 December 2023 -The South Africa Health Products Regulatory Authority (SAHPRA), in collaboration with Pharmacometrics Africa and the Department of Pharmacy and Pharmacology at the University of Witwatersrand, is responsive to the evolving and advancing healthcare technology innovation by developing relevant training for its...

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]]> SAHPRA’s position on Semaglutide compounded products https://www.sahpra.org.za/news-and-updates/sahpras-position-on-semaglutide-compounded-products/ Wed, 13 Dec 2023 12:43:33 +0000 https://www.sahpra.org.za/?p=15553 Pretoria, 13 December 2023 – The South African Health Products Regulatory Authority (SAHPRA) recently released a media statement on the falsified Ozempic products currently being sold on the market and online, specifically unauthorised Ozempic/semaglutide-containing products. SAHPRA has registered one product which contains semaglutide called Ozempic....

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]]> SAHPRA Service Desk back online https://www.sahpra.org.za/news-and-updates/sahpra-service-desk-back-online/ Wed, 13 Dec 2023 10:23:51 +0000 https://www.sahpra.org.za/?p=15542 The SAHPRA Service Desk is back online. ICT has completed its necessary maintenance, and services have been restored. We sincerely apologise for any inconvenience caused.

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]]> Public urged to use registered Ozempic products https://www.sahpra.org.za/news-and-updates/public-urged-to-use-registered-ozempic-products/ Mon, 11 Dec 2023 09:12:02 +0000 https://www.sahpra.org.za/?p=15501 Pretoria, 11 December 2023 – The South African Health Products Regulatory Authority (SAHPRA) is aware of the falsified Ozempic products currently being sold on the market and online. SAHPRA has been informed of advertisements regarding unauthorised Ozempic/semaglutide-containing products that are being disseminated through radio stations...

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]]> SAHPRA Service Desk unavailability due to maintenance https://www.sahpra.org.za/news-and-updates/sahpra-service-desk-unavailability-due-to-maintenance/ Fri, 08 Dec 2023 08:43:29 +0000 https://www.sahpra.org.za/?p=15491 The SAHPRA Service Desk will be unavailable from Friday, 08 December 2023 until Monday, 11 December 2023 as the ICT team will be performing maintenance. During this time, users will be unable to send queries, lot release applications or respond to existing queries using the system. Users...

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]]> OpEd – Leveraging South Africa’s maturity level 3 to strengthen regulatory systems in the Africa region: What is next? https://www.sahpra.org.za/news-and-updates/oped-leveraging-south-africas-maturity-level-3-to-strengthen-regulatory-systems-in-the-africa-region-what-is-next/ Thu, 07 Dec 2023 11:51:00 +0000 https://www.sahpra.org.za/?p=15476 The establishment of the African Medicines Agency (AMA) will significantly contribute to the improvement of healthcare delivery across the continent and better overall health of African citizens. Africa continues to be a growing continent in many aspects. It is expected that the population of young...

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