17 May Regulatory experts from African countries visit the Paul-Ehrlich-Institut to discuss future cooperation with vaccine experts

Posted at 17:40h in News & Updates

17 May 2022 At a four-day meeting at the Paul-Ehrlich-Institut, representatives of the regulatory authorities in Ghana (Food and Drugs Authority, FDA), Rwanda (Food and Drugs Authority, FDA), South Africa (South African Health Products Regulatory Authority, SAHPRA) and Senegal (Agence sénégalaise de Réglementation Pharmaceutique, ARP) discussed future cooperation with vaccine...

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12 May Safety of the COVID-19 Vaccine Janssen – response to restrictions imposed in the United States

Posted at 16:21h in News & Updates, Press Releases

12 May 2022Embargo: Immediate release In both the United States and South Africa, the COVID-19 Vaccine Janssen has been approved as a single primary vaccination dose, a single booster dose at least two months after the primary vaccination dose, and as a heterologous booster dose following...

Mat Napo via Unsplash

11 Mar SAHPRA clarifies the risks and benefits of the Pfizer Comirnaty vaccine

Posted at 18:05h in News & Updates, Press Releases

11 March 2022 Embargo: Immediate release The South Africa Health Products Regulatory Authority (SAHPRA) has noted that a safety report in relation to the COVID-19 Pfizer Comirnaty vaccine directed to the United States Food and Drug Administration (FDA) has been distributed on various communication platforms in South...

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03 Sep FDA’s stance on ivermectin aligned to SAHPRA’s position

Posted at 08:35h in News & Updates, Press Releases

3 September 2021 The South African Health Products Regulatory Authority (SAHPRA) is aligned with the United States Food and Drug Administration (USFDA) call to not use Ivermectin for the treatment of COVID-19. This stance is reflected in the SAHPRA statement, dated 28 January 2021, outlining SAHPRA’s views on Ivermectin and the Controlled Compassionate Use Programme. SAHPRA...

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13 Jun SAHPRA update COVID-19 Vaccine Janssen – FDA Developments

Posted at 08:28h in News & Updates, Press Releases

13 June 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, with conditions. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965. The Covid-19 Vaccine Janssen is an adenovirus type 26 vectored vaccine indicated for...

FDA Tag

17 May Regulatory experts from African countries visit the Paul-Ehrlich-Institut to discuss future cooperation with vaccine experts

12 May Safety of the COVID-19 Vaccine Janssen – response to restrictions imposed in the United States

11 Mar SAHPRA clarifies the risks and benefits of the Pfizer Comirnaty vaccine

03 Sep FDA’s stance on ivermectin aligned to SAHPRA’s position

13 Jun SAHPRA update COVID-19 Vaccine Janssen – FDA Developments

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