Communication to Stakeholders – COVI-Vig reporting system
SAHPRA has implemented the COVI-Vig reporting system for vigilance and monitoring of health products being used
for prevention or treatment of COVID-19 outside of a clinical trial and outside of the MEURI framework
20 August 2020
SAHPRA Approves SARS-Cov-2 serology Test Kits
SAHPRA has issued Section 21 authorisation for one serological test kit
(rapid, point of care test kit) and five lab-based SARS-Cov-2 serology tests
24 August 2020
Meet three new Senior Managers at SAHPRA
SAHPRA made three new appointments: Senior Manager: Clinical Evaluation Management; Programme Manager: Backlog Project and Senior Manager: Medical Devices and Radiation Control
01 June 2020
Communication to Industry- Scheduling Status: THC and CBD
In Government Notice No. 586, Government Gazette No. 43347, issued on 22 May 2020, the Minister of Health has amended the schedule status of THC and CBD health products. Click here to read more
May 2020
Pharmaceuticals and Vaccines Suppliers for Covid-19 pandemic
SAHPRA and Business 4 South Africa (B4SA) under the Pharmaceutical and Vaccines working stream are collaborating on providing industry with regulatory guidance to ensuring essential COVID-19 related medicines supply in both the public and private sectors as well as managed in a clear and transparent way.
May 2020
GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRs) REPORTING FOR HEALTHCARE PROFESSIONALS
Comments to be send to pvqueries@sahpra.org.za
Closing date : 30 June 2020
COVID-19 – The Appropriate place for Rapid Test Kits
In line with the recommendation of the South African National Institute for
Communicable Disease (NICD) and the recommendation of the World Health Organization (WHO),SAHPRA wishes to point out that the so-called Rapid test kits (serological test kits) that are being offered for the diagnosis of COVID-19 are not suitable for this purpose
30 March 2020
Guidelines on Influenza Vaccination for 2020
As we move into the influenza season we have to ensure that the most vulnerable groups get the vaccine.
This means that all available vaccines (whether available in the public or private sector) must be equitably available to all those that need it
26 March 2020
SAHPRA responds to coronavirus (COVID-19): Medicines/medical devices supply challenges
The new coronavirus (COVID-19) will continue to have far-reaching consequences on public health as well as manufacturing and business in general across the globe. SAHPRA has put in place a series of initiatives aimed at minimising the potential negative impact of the pandemic on the availability of medicines and medical devices in South Africa.
17 March 2020
UNODC
SAHPRA represented at the Commission on Narcotic Drugs (CND) 63rd session in Vienna.
SAHPRA will be attending the United Nations Office on Drugs and Crime (UNODC) Commission on Narcotic Drugs (CND) 63rd session in Vienna from the 2 March 2020 to 6 March 2020. Ms Momeena Omarjee, Manager: Names and Scheduling will attend the event.
28 February 2020
Interview with SAHPRA Board Chair, Prof Helen Rees (SAHPRA 2020)
To say SAHPRA inherited a disaster from the overwhelmed MCC is an understatement. With a massive backlog of around 16 000 medicine regulatory applications, the organisation had a steep hill to climb.
4 February 2020
Top Story- Interview with SAHPRA’S new CEO
Heading up the South African Health Products Regulatory Authority (SAHPRA) and tackling the chaos left behind by the defunct Medicines Control Council (MCC) was always going to take someone exceptional. In Dr Boitumelo Semete-Makokotlela, the SAHPRA board may well have found the answer.
2 February 2020
Important Notice – Cannabis Walk-In Applications
All cannabis-related walk-in queries and applications will only be done on Tuesdays from 09h00 to 15h30
23 January 2020
Cannabis Q & A
The Cannabis Q & A document will assist in providing clarity on issues relating to cannabis.
13 December 2019
CODEINE-CONTAINING MEDICINES
The South African Health Products Authority (SAHPRA) is reviewing the scheduling status of codeine following the growing use of the non-medicinal use of codeine-containing medicines.
21 January 2020
Cannabis Sample Application Form
Are you experiencing difficulty in navigating the Cannabis Application Process?
20 January 2020
API names updated to align with WHO INN
Update – SAHPRA has updated and amended the approved South African API names to bring them in line with WHO INN. The amendment process allows for a five-year transition period to allow industry to bring medicine labelling in line with the policy commencing in June 2019 and ending in June 2024.
02 August 2019
Submission of Business as Usual (BAU) registration and variation applications
To Industry Partners – The aim of this communication is to guide industry regarding the submission of BAU registration and variation applications for human medicines (excluding Complementary Medicines).
01 Aug 2019
