Health Product literacy top of mind as SAHPRA announces online medicines directory
28 June 2022 The South African Health Products Authority (SAHPRA) is pleased to
28 June, 2022
SAHPRA’s MOU with SANAS extended
28 June 2022 Pretoria – The South African Health Products Regulatory Authority (
28 June, 2022
SAHPRA registers the COVID-19 vaccine, Coronavac
Embargo: Immediate release Pretoria, 24 June 2022 – The South African Health Pro
24 June, 2022
SAHPRA Announces Approval of Breakthrough Treatments for Children with HIV
Embargo: Immediate release Pretoria, 23 June 2022 – SAHPRA has registered a new
23 June, 2022
SAHPRA’s use of the Med Safety app in the spotlight
23 June 2022 The South African Health Products Regulatory Authority (SAHPRA) has
23 June, 2022
Learn more about monkeypox as we record first confirmed case in SA
23 June 2022 South Africa has recorded its first case of monkeypox today, 23 Jun
23 June, 2022
The Dynamics of Assuming a New CEO or Leadership Role under Global Lockdown Restrictions
17 June 2022 CEO Perspectives and Horizons as Covid-19 takes a grip The SAHPRA C
17 June, 2022
SAHPRA registers a vaccine and provides emergency use authorisation of health products in the fight against COVID-19
07 June 2022 Embargo: Immediate release1. The COVID-19 vaccine LHC has been regi
07 June, 2022
SAHPRA statement on the termination of the “Ivermectin Controlled Compassionate Use Access Programme”
30 May 2022 Embargo: Immediate release Pretoria, 30 May 2022 – The use of
30 May, 2022
Update: SAHPRA Statement on the ANHP Judgement
27 May 2022 Embargo: Immediate release On 7 May 2022, the South African Health P
27 May, 2022
Regulatory experts from African countries visit the Paul-Ehrlich-Institut to discuss future cooperation with vaccine experts
17 May 2022 At a four-day meeting at the Paul-Ehrlich-Institut, representatives
17 May, 2022
Safety of the COVID-19 Vaccine Janssen – response to restrictions imposed in the United States
12 May 2022 Embargo: Immediate release In both the United States and South Afric
12 May, 2022
SAHPRA Statement on the ANHP Judgement
07 May 2022 Embargo: Immediate release Following the ruling by the Supreme Court
07 May, 2022
SAHPRA Comments on ACDP court matter on vaccines for minors
03 May 2022 Embargo: Immediate release Pretoria, 3 May 2022 – In October 2
03 May, 2022
SAHPRA Responds to the ANHP Judgement
20 April 2022 Embargo: Immediate release The South Africa Health Products Regula
19 April, 2022
SAHPRA CT Office Relocation
08 April 2022 The South African Health Products Regulatory Authority (SAHPRA) of
08 April, 2022
SAHPRA Responds to claims that hawkers are selling illicit medication in Cape Town
08 April 2022 Embargo: Immediate release The South Africa Health Products Regula
08 April, 2022
SAHPRA assigns a non-compliant rating to the Emergent BioSolutions COVID-19 facility
31 March 2022 SAHPRA has assigned a non-compliant rating to the Emergent BioSolu
31 March, 2022
SAHPRA clarifies the risks and benefits of the Pfizer Comirnaty vaccine
11 March 2022 Embargo: Immediate release The South Africa Health Products Regula
11 March, 2022
SAHPRA has authorised access to molnupiravir
17 February 2022 Embargo: Immediate release Until recently, the treatment option
17 February, 2022
SAHPRA registers two COVID-19 vaccines
Embargo: Immediate release SAHPRA registered two COVID-19 vaccines: the COMIRNAT
07 February, 2022
Vaccines – News and updates
7 February 2022 SAHPRA registered the SAHPRA registered the Comirnaty vaccine fr
07 February, 2022
SAHPRA and USP Announce MOU to Advance Regulatory Oversight for Medical Products in South Africa
14 January 2022 Embargo: Immediate release Joint Media Statement The South Afric
14 January, 2022
SAHPRA approval of second/booster dose of the COVID-19 vaccine Janssen
23 December 2021 Embargo: Immediate release The South African Health Products Re
08 December, 2021SAHPRA approval of booster dosing with the Pfizer (Comirnaty®) COVID-19 vaccine
8 December 2021 Embargo: Immediate release The South African Health Products Aut
08 December, 2021
SAHPRA Office Closure
7 December 2021 Please note that the SAHPRA office will be closed for the festiv
07 December, 2021SAHPRA and the Pfizer Booster (3rd dose) Vaccine
26 November 2021 Embargo: Immediate release SAHPRA has received an application f
26 November, 2021SAHPRA announces results of onsite inspection at Emergent BioSolutions facility in Baltimore, Maryland
22 November 2021 In June 2021, SAHPRA communicated that South Africa would not a
22 November, 2021
Update on the SAHPRA review of the Sputnik V Vaccine
18 October 2021 SAHPRA has been engaged in a rolling review of the data for the
18 October, 2021Extension of Post Importation Testing Exemptions
30 September 2021 Attention all stakeholders Post Importation Testing Exemptions
30 September, 2021SAHPRA update on Section 21 authorisation for Pfizer Comirnaty Vaccine
10 September 2021 The South African Health Products Authority (SAHPRA) has appro
10 September, 2021
FDA’s stance on ivermectin aligned to SAHPRA’s position
3 September 2021 The South African Health Products Regulatory Authority (SAHPRA)
03 September, 2021
SAHPRA’s vaccine registration process and role of the SAHPRA Board
30 July 2021 The South African Health Products Regulatory Authority (SAHPRA) is
30 August, 2021
SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 VaccineS
20 August 2021 The South African Health Products Regulatory Authority (SAHPRA) h
20 August, 2021
Health regulatory bodies condemn looting and violence targeting health care facilities
19 July 2021 As South Africa’s statutory health regulatory bodies, the South Afr
19 July, 2021How COVID-19 vaccines are regulated for safety and effectiveness
13 July 2021 Healthcare professionals and public health authorities have a centr
13 July, 2021
SAHPRA AUTHORISES THE CORONAVAC VACCINE WITH CONDITIONS
03 July 2021 The South African Health Products Regulatory Authority (SAHPRA) has
03 July, 2021
Media release on the approval process of Covid vaccines
01 July 2021 The South African Health Products Regulatory Authority (SAHPRA) has
01 July, 2021
SAHPRA’s Response to the Economic Freedom Fighters (EFF) March
25 June 2021 The South African Health Products Regulatory Authority (SAHPRA) is
25 June, 2021SAHPRA and the Sinopharm Vaccine
23 June 2021 SAHPRA has received documentation for the Sinopharm vaccine develop
23 June, 2021
SAHPRA update on Vaccine Approvals
21 June 2021 The South African Health Products Regulatory Authority (SAHPRA) is
21 June, 2021
SAHPRA update COVID-19 Vaccine Janssen – FDA Developments
13 June 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, wi
13 June, 2021
SAHPRA Represented at A side event at the 30th Commission on Crime Prevention and Criminal Justice
11 June 2021 Background World Health Organization (WHO) estimates from 2017 indi
11 June, 2021SAHPRA update on the COVID-19 Vaccine Janssen – GMP Concerns
7 June 2021 SAHPRA registered the Covid-19 Vaccine Janssen on 31 March 2021, wit
07 June, 2021Section 21 extension (Ventilators – invasive and non-invasive)
07 June 2021 To whom it may concern We draw your attention to the provisions o
05 June, 2021Covid-19 has catapulted Boitumelo Semete- Makokotlela into the public eye
24 May 2021 Boitumelo Semete-Makokotlela’s children have nicknamed her “meeting”
24 May, 2021Guidance on the use of the Janssen Ad26.COV2.S (COVID-19) vaccine in pregnant and lactating women
29 April 2021 Background Pregnant women are at higher risk of severe COVID-19 co
29 April, 2021
Extension of Post Importation Testing Exemptions
23 April 2021 Post Importation Testing Exemptions (PITE) granted due to COVID-19
23 April, 2021
SAHPRA launches the Med Safety App for self-reporting of suspected Adverse Drug Reactions by the Public and Healthcare Professionals
22 April 2021 SAHPRA is pleased to announce the launch of the Med Safety App. Th
22 April, 2021SAHPRA Statement – Update on Sisonke Phase 3B Implementation Study
17 April 2021 SAHPRA has engaged with the Sisonke Phase 3B Implementation Study
17 April, 2021Statement by the Minister of Health, Dr Zwelini Mkhize, on the FDA’s Temporary Suspension of Johnson and Johnson vaccine rollout in the United States
13 April 2021 We have noted the decision taken by the Food and Drug Administrati
13 April, 2021SAHPRA Statement- High Court Order – Ivermectin
9 April 2021 On 6 April 2021 the Pretoria High Court issued a court order pertai
09 April, 2021SAHPRA registers Covid-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) with conditions
01 April 2021 The South African Health Products Authority (SAHPRA) registered th
01 April, 2021
SAHPRA has NOT authorised Ivermectin for the treatment of COVID-19
29 March 2021 The SABC placed an erroneous report that “SAHPRA has agreed to all
29 March, 2021
Regulatory stringency and adaptability in the time of COVID-19
25 March 2021 As the entire world ushered in 2020, no one had any idea how life,
25 March, 2021SAHPRA implements a new and improved online submission portal for Section 21 applications
19 March 2021 SAHPRA has implemented a new and improved online submission portal
22 March, 2021
SAHPRA registers Soolantra 10mg/g Cream- An ivermectin formulation
19 March 2021 On 16 March 2021 SAHPRA registered Soolantra 10mg/g cream formulat
19 March, 2021
SAHPRA and the Pfizer/Biontech Comirnaty Vaccine
16 March 2021 SAHPRA has approved the Section 21 application for the Pfize
16 March, 2021SAHPRA clarifies its stance on Ivermectin
03 February 2021 There is an erroneous notion that SAHPRA “buckled under pressur
03 February, 2021
SAHPRA AUTHORISES COVISHIELD – AN ADENOVIRUS-VECTORED VACCINE FOR THE PREVENTION OF COVID-19
27 January 2021 In an effort to enable and support the country’s response in fig
27 January, 2021
SAHPRA OTC ONLINE DIRECTORY
06 January 2021 SAHPRA is pleased to announce the commencement of the build of a
06 January, 2021Extension of Post Importation Testing Exemptions
22 December 2020 Post Importation Testing Exemptions (PITE) granted due to COVID
22 December, 2020
Frequently Asked Questions: New Variant of SARS-CoV-2 in South Africa
19 December 2020 Health Minister Dr Zweli Mkhize on Friday announced that a vari
19 December, 2020
INFORMATION AND GUIDANCE ON IMMUNIZATION WITH THE NEW COVID-19 VACCINES
10 December 2020 What is a Covid-19 Vaccine? A COVID‑19 vaccine is any of severa
10 December, 2020
INFORMATION AND GUIDANCE ON APPLICATION FOR REGISTRATION OF CANDIDATE COVID-19 VACCINE
04 December 2020 Coronavirus disease (COVID-19) is an infectious disease caused
04 December, 2020
BACKLOG CLEARANCE NEWSLETTER COMMUNICATION
19 November 2020 The Backlog Clearance Team has been made aware of a miscommunic
19 November, 2020HEALTH PRODUCT APPLICATION STATUS CHECKER
SAHPRA has implemented an application status checker. This new tool is listed un
03 November, 2020SAHPRA APPROVES SARS-Cov-2 SEROLOGY TEST KITS
Embargo: Immediate release SAHPRA has issued Section 21 authorisation for one se
25 August, 2020COMMUNICATION TO STAKEHOLDERS – COVI-VIG REPORTING SYSTEM
In the interest of public health, SAHPRA has launched the COVI-Vig reporting sys
20 August, 2020SAHPRA BACKLOG CLEARANCE PROGRAMME NEWSLETTER
The Backlog Clearance Programme has received applications for Re-submission Wind
11 August, 2020
SUBMISSION OF BAU REGISTRATION AND VARIATION APPLICATIONS
Business-As-Usual (BAU) process have been amended to be in line with new regulat
01 August, 2020
COMMUNICATION TO INDUSTRY- SCHEDULING STATUS: THC AND CBD
In its 25 November 2019 communication to stakeholders about cannabis and related
28 May, 2020PHARMACEUTICALS AND VACCINES SUPPLIERS FOR COVID-19 PANDEMIC
SAHPRA and B4SA under the Pharmaceutical and Vaccines working stream are collabo
09 May, 2020COVID-19 – THE APPROPRIATE PLACE FOR RAPID TEST KITS
In line with the recommendation of the South African National Institute for Comm
30 March, 2020
GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRS) REPORTING FOR HEALTHCARE PROFESSIONALS
The document in the link below has been prepared to serve as a guideline to heal
28 March, 2020
GUIDELINES ON INFLUENZA VACCINATION FOR 2020
The World Health Organisation (WHO) has declared COVID-19 to be a Public Health
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 o
17 March, 2020
UNODC
SAHPRA represented at the Commission on Narcotic Drugs (CND) 63rd session in Vie
28 February, 2020
04 February, 2020TOP STORY- INTERVIEW WITH SAHPRA’S NEW CEO
Download PDF
02 February, 2020
CODEINE-CONTAINING MEDICINES
SAHPRA- REVIEWING SCHEDULING STATUS OF CODEINE-CONTAINING MEDICINES The South Af
29 January, 2020
IMPORTANT NOTICE – CANNABIS WALK-IN APPLICATIONS
All walk-in clients who want to lodge applications or have queries mus
23 January, 2020
CANNABIS SAMPLE APPLICATION FORM
Download PDF
20 January, 2020CANNABIS Q & A
Download PDF
13 December, 2019
API NAMES UPDATED TO ALIGN WITH WHO INN
The South African Health Products Regulatory Authority (SAHPRA) is updating cert
02 August, 2019WHO OR WHAT IS SAHPRA
10 May 2019 SAHPRA is the South African Health Products Regulatory Authority. It
10 May, 2019
