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On 31 December 2019, the World Health Organization (WHO) reported a cluster of pneumonia cases in Wuhan City, China. ‘Severe Acute Respiratory Syndrome Coronavirus 2’ (SARS-CoV-2) was confirmed as the causative agent of what we now know as ‘Coronavirus Disease 2019’ (COVID-19). Since then, the virus has spread to more than 100 countries, including South Africa.
This document provides an overview of desired skillsets for persons required by SAHPRA who will be considered to serve in the African Traditional Medicines Working Group to support SAHPRA in considering and developing the regulatory approach for ATMs and make recommendations to the SAHPRA Chief Executive Officer (CEO).
Test kits are medical devices. Serological test kits (Rapid test kits), are finger-prick tests that do not need to be processed by the lab. The rapid test kits are able to detect if you have developed antibodies to COVID-19. Rapid test kits cannot be used for diagnosis.
Learn more about Rapid test kits
In the interest of public health, SAHPRA has launched 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.
The South African Health Products Regulatory Authority (SAHPRA) aims to clear its backlog within a period of two years. The backlog clearance programme went live on 1 August 2019.
The backlog clearance project will assume a three-pronged approach:
- Reducing the number of applications that require evaluation
- Segment and prioritise remaining applications
- Design and implement new models for evaluation
The South African Health Products Regulatory Authority (SAHPRA) is reviewing the scheduling status of codeine following the growing use of the non-medicinal use of codeine-containing medicines. Codeine is classified as an opioid. Opioids are narcotics with a known potential for dependence. Codeine is administered in liquid or solid form (tablet/capsule), either alone or in combination with other active pharmaceutical ingredients
Safety alerts
Medicine safety alert: new restrictions on the use of gamma benzene hexachloride (lindane) – containing shampoos
May 2009
The Medicines Control Council (MCC) alerts all health care professionals to the correct route of administration of Rotarix vaccine.
March 2008
The Medicines Control Council (MCC) alerts all health care professionals to new prescribing information for promethazine.
September 2007
MSA Ketoconazole And Domperidone
MEDICINE SAFETY ALERT: INTERACTION BETWEEN KETOCONAZOLE AND DOMPERIDONE AND THE RISK OF QT PROLONGATION
March 2008
PRODUCT RECALLS
Procter & Gamble Vicks Public Alert VVR.2.2017
Procter & Gamble South African Trading (Pty) Ltd, in consultation with the Medicines Control Council, wishes to alert the public that a small amount of counterfeit Vicks…
10 February 2017
Lethyl 30 mg Aspen Pharmacare Recall Letter
This recall is initiated as a result of product quality complaint logged with Aspen Pharmacare due to the discloration of Lethyl 30 mg tablets
31 July 2015
Bioplus AdcockIngram Recall Letter
Following a customer complaint, we have identified the vitamin premix used in the manufacture of the affected product and batches contain additional vitamins and minerals
October 25, 2019
Benylin Johnson & Johnson Recall letter
Johnson & Johnson (Pty) Ltd, in consultation withe Medicine Control Council, is recalling the following batches of BENYLIN® products
1 July 2015
Publications
ANNUAL REPORT
The annual report has been prepared in accordance with the guidelines on the annual report as issued by the National Treasury.
2018/19
Cannabis and related substances A5 final
CANNABIS AND RELATED SUBSTANCES
25 October 2019
Registrations of Medicines
NOTIFICATION OF REGISTRATION OF MEDICINES BY THE ACTING CEO OF SAHPRA IN TERMS OF SECTION 17 OF THE MEDICINES AND RELATED SUBSTANCES ACT, 1965 (ACT 101 OF 1965)
October 2019
SAHPRA Fees 2019
Fees payable in terms of the provisions of the medicines and related substances act, 1965
18 June 2019
Workshops and Conferences
Assessing similarity of biosimilars
In South Africa, potential manufacturers of biosimilars lack a roadmap for comparing…
12 February 2018
DC formulation and delivery
Issues Related to the Formulation and Delivery of Pharmaceutical Proteins
25 November 2016
Immunogenicity of biopharmaceuticals
Southern African Regional and International Regulatory Biotechnology Workshop 2007
9-10 November 2016
What are biotechnology products?
Southern African Regional and International Regulatory Biotechnology Workshop 2007
02 August 2016
SOCIAL MEDIA FEEDS
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