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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

3 weeks ago
Photos from Sahpra_ZA's post

Media Release-SAHPRA approves SARS-COV-2 Serology test kits.

1 month ago
SAHPRA salutes ALL Women who have over the years have persevered and have contributed so much to ALL our lives!

SAHPRA salutes ALL Women who have over the years have persevered and have contributed so much to ALL our lives!

1 month ago
Photos from Sahpra_ZA's post

New office space! SAHPRA Reception area.
2nd Floor, Building A, Loftus Office Park.
Arcadia, Pretoria

1 month ago
Photos from Sahpra_ZA's post

SAHPRA Relocates to Loftus Office Park

New Address : Building A
Loftus Park
416 Kirkness Street
Arcadia
Pretoria

Please bear in mind that we are still working remotely.

1 month ago
Photos from Sahpra_ZA's post

Vacancies!!!Vacancies!!!

2 months ago

Health Products Registration: Central to the fight against COVID-19

2 months ago

Our website encountered a technical glitch and we lost some data. This has been rectified.

2 months ago

The SAHPRA website is currently under maintenance. Our IT teams is working on getting it up again

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[Speech] President @CyrilRamaphosa urges South Africans to continue observing vital #COVID19 safety rules as government moves to further relax the country’s lockdown restrictions

Read full speech here: http://bit.ly/32Bh7zF

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