23 April 2021 Post Importation Testing Exemptions (PITE) granted due to COVID-19 pandemic Post importation testing exemption approvals granted since March 2020 due to the Covid-19 pandemic, are extended to 30 September 2021 without further need of an application thereof. The initial approval date was extended to...
22 April 2021 SAHPRA is pleased to announce the launch of the Med Safety App. The Med Safety App is a mobile application (App) that is designed to simplify and promote the reporting of suspected adverse drug reactions (ADRs), including adverse events following immunisation (AEFIs) by...
17 April 2021 SAHPRA has engaged with the Sisonke Phase 3B Implementation Study team and Janssen Pharmaceutica. The focus of the engagement was on the safety data reported from the Sisonke study, following administration of the COVID-19 vaccine Janssen, as well as the adverse events reported...
13 April 2021 We have noted the decision taken by the Food and Drug Administration in the United States of America to advise the temporary suspension of the Johnson and Johnson vaccine rollout in the US. This has occurred to due reports of 6 females who developed...
9 April 2021 On 6 April 2021 the Pretoria High Court issued a court order pertaining to four cases that were brought against SAHPRA and the Minister of Health regarding access to Ivermectin for use in COVID-19. The court order was as a result of settlement...
01 April 2021 The South African Health Products Authority (SAHPRA) registered the Covid-19 Vaccine Janssen on 31 March 2021. The registration was done in terms of Section 15(6a) of the Medicines and Related Substance Act 101 of 1965, which allows SAHPRA to register a medicine subject...
29 March 2021 The SABC placed an erroneous report that “SAHPRA has agreed to allow the use of Ivermectin for the treatment of COVID-19”. This is grossly untrue, misleading to the public and irresponsible and could have dire consequences. The position of SAHPRA remains steadfast. Ivermectin may...
25 March 2021 As the entire world ushered in 2020, no one had any idea how life, businesses, governments, and nations would be disrupted. The “normal” that we were so familiar with got eroded rapidly as the pandemic gripped society with deadly force. Health regulatory authorities were...
19 March 2021 SAHPRA has implemented a new and improved online submission portal for Section 21 applications (Category A Medicines). This has been in development over the past few months. The new submission portal will improve the communication timelines between SAHPRA and applicants. It also allows the...
19 March 2021 On 16 March 2021 SAHPRA registered Soolantra 10mg/g cream formulation, which contains ivermectin. The holder of the certificate of registration is Galderma South Africa. Soolantra Cream is indicated for the topical treatment of moderate to severe inflammatory lesions of papulopustular rosacea in adult...
