SAHPRA signs MoU with Medicines Control Authority of Zimbabwe
Pretoria, 12 January 2024 – The South African Heal
12 January, 2024Message from the SAHPRA CEO | Dr Boitumelo Semete-Makokotlela
2024 | Embracing new partnerships and overcoming c
04 January, 2024SAHPRA recalls Lubri-A, sterile lubricating gel
Pretoria, 19 December 2023 – The South African Hea
20 December, 2023SAHPRA invests in capacity building with a focus on patient safety
Pretoria, 14 December 2023 -The South Africa Healt
14 December, 2023SAHPRA’s position on Semaglutide compounded products
Pretoria, 13 December 2023 – The South African Hea
13 December, 2023SAHPRA Service Desk back online
The SAHPRA Service Desk is back online. ICT has co
13 December, 2023Public urged to use registered Ozempic products
Pretoria, 11 December 2023 – The South African Hea
11 December, 2023SAHPRA Service Desk unavailability due to maintenance
The SAHPRA Service Desk will be unavailable from F
08 December, 2023OpEd – Leveraging South Africa’s maturity level 3 to strengthen regulatory systems in the Africa region: What is next?
The establishment of the African Medicines Agency
07 December, 2023SAHPRA currently conducting a Stakeholder Satisfaction Survey
Pretoria, 06 December 2023 – The South African Hea
06 December, 2023SAHPRA office closure during festive season
SAHPRA offices will be closed for the festive seas
29 November, 2023SAHPRA encourages reporting side effects this MedSafetyWeek
Pretoria, 06 November 2023 – The South African Hea
06 November, 2023Launching SAHPRA’s Chatbot – meet Reggie!
The South African Health Products Regulatory Autho
03 November, 2023Update on COVID-19 vaccines
Pretoria, 26 October 2023 – The South African Heal
26 October, 2023SAHPRA aware of Illicit bulk sales of codeine-containing mixtures exposed by Carte Blanche
Pretoria, 10 October 2023 –The South African Healt
10 October, 2023SAHPRA acknowledges World Patient Safety Day and World Pharmacist Day
The South African Health Products Regulatory Autho
26 September, 2023SAHPRA hosts 3rd AU-3S Steering Group Meeting, new member countries welcomed
Pretoria, 14 September 2023 –The South African Hea
14 September, 2023Public Alert – Ms Pamela Mohlabe was dismissed by SAHPRA following evidence of fraudulent activities
Pretoria, 04 September 2023 –The South African Hea
04 September, 2023USP welcomes Executive Delegation from SAHPRA
August 30, 2023, Rockville, MD – United States Pha
31 August, 2023SAHPRA Earns a Regulatory Accolade of Note
SAHPRA has been designated as a Regional Centre of
25 August, 2023Africa CDC donates equipment to SAHPRA to support regulatory functions in vaccine manufacturing
Pretoria, 10 August 2023 – The Africa Centre for D
10 August, 2023SCA Judgement Ruling
The South Africa Health Products Regulatory Author
02 August, 2023SAHPRA signs MOU with Egyptian Drug Authority
Pretoria, 11 July 2023 -The South Africa Health Pr
11 July, 2023
ICMRA statement on the safety of COVID-19 vaccines
The South Africa Health Products Regulatory Author
07 July, 2023SAHPRA invests in capacity building – announcing new graduates
The South Africa Health Products Regulatory Author
05 June, 2023SAHPRA perspectives on Coronavirus SARS-COV-2
Pretoria, 15 May 2023 -The South Africa Health Pro
15 May, 2023COVID-19 Vaccine Janssen update – Third fatal case of Guillain-Barré syndrome
Pretoria, 21 April 2023 – The South African
21 April, 2023SAHPRA withdraws pholcodine-containing medicines from SA market
Pretoria, 06 April 2023 – The South African Health
06 April, 2023Fake medicines are a dangerous threat in Africa: 3 ways to spot them
Every year, the world commemorates World Tuberculo
06 April, 202324 March is World TB Day
Every year, the world commemorates World Tuberculo
24 March, 2023SAHPRA exhibits MedSafety App at 2023 Pharmacy Show
Johannesburg – The South African Health Prod
22 March, 2023SAHPRA participates in 2023 SAAHIP Annual Conference
KwaZulu-Natal – The South African Health Pro
15 March, 2023Removing Barriers and Promoting Access to Health Products
1 March 2023 The COVID-19 pandemic turned the spot
01 March, 2023SAHPRA hosts Regional QMS Technical Working Group Workshop
Pretoria, 23 February 2023 – The South Afric
23 February, 2023SAHPRA registers Paxlovid, an anti-viral medicine for COVID-19
Pretoria, 30 January 2023 – The South African Heal
30 January, 2023Register for an Africa Continental Good Regulatory Practice Workshop
The US Agency for International Development (USAID
04 January, 2023Long Acting Cabotegravir, a preventative ARV for HIV
Many of you have heard about this strange sounding
15 December, 2022SAHPRA registers new long-acting HIV Pre-exposure prophylaxis
Pretoria, 2 December 2022 – The South African Heal
02 December, 2022SAHPRA celebrates the conclusion of the backlog clearance project
Pretoria, 2 December 2022 – With the establishment
02 December, 2022SAHPRA approves antigen self-test kits for public use
Pretoria, 24 November 2022 – In the past year, the
24 November, 2022SAHPRA Statement – Latest Development on Ivermectin Court Case
Pretoria, 23 November 2022 – On 6 April 2021, the
23 November, 2022SAHPRA registers COMIRNATY’s paediatric and adult vaccines
22 November 2022 Embargo: Immediate release Pretor
22 November, 2022Face to Face: Prof Helen Rees on SAHPRA, women’s rights, and her appetite for justice
Pretoria, 21 November 2022 – As a rebellious teena
22 November, 2022SAHPRA receives Accolade from the National Press Club (NPC)
Pretoria, 4 November 2022 – The South African Heal
04 November, 2022SAHPRA is investigating Tembisa Hospital procurement of health products
Pretoria, 4 November 2022 – The South African Heal
04 November, 2022SAHPRA visits Nelson Mandela University
Gqerberha, 21 October 2022 – The South African Hea
21 October, 2022SAHPRA collaborates with Germany’s BloodTrain programme
Pretoria, 10 October 2022 – The South African Heal
10 October, 2022SAHPRA alerts the public about contaminated health products
Pretoria, 10 October 2022 – The South African Heal
10 October, 2022SAHPRA undergoes AUDA-NEPAD in-country assessment
Pretoria, 07 October 2022 – The South African Heal
07 October, 2022SAHPRA visits Wits University
Pretoria, 06 October 2022 – The South African Heal
06 October, 2022SAHPRA receives Accolade from the World Health Organisation
Pretoria, 5 October 2022 – The South African
05 October, 2022Update on COVID-19 health products
UPDATE ON COVID-19 HEALTH PRODUCTS: SAHPRA registe
28 September, 2022
SAHPRA acknowledges World Patient Safety Day
Patient safety resonates with SAHPRA’s mission of
18 September, 2022COVID-19 Vaccine Janssen update – Second fatal case of Guillain-Barré syndrome
Pretoria, 12 September 2022 – On the 04th of
12 September, 2022SAHPRA visits universities
KwaZulu-Natal, 12 September 2022 – SAHPRA is plann
12 September, 2022SAHPRA and Germany’s GHPP-PharmTrain Project discuss future collaboration
Pretoria, 26 August 2022 – Representatives of the
26 August, 2022
SAHPRA website now has a revamped navigation
Pexels via Pixabay
08 August, 2022SAHPRA educates, informs during SAAPI Conference 2022
Johannesburg, 06 August 2022 – The South Afr
06 August, 2022Update on COVID-19 Vaccine Janssen – Guillain-Barré syndrome
04 August 2022 On 31 March 2021, SAHPRA approved t
04 August, 2022SAHPRA CEO wins Management accolade at “Science Oscars”
Pretoria, 22 July 2022 – SAHPRA CEO, Dr Boit
22 July, 2022SAHPRA’s Radiation Control Unit delivers Compliance Workshop @ NICD
21 July 2022 Johannesburg – The Radiation Control
21 July, 2022SAHPRA clarifies process for importation of medicines
Embargo: Immediate release Pretoria, 20 July 2022
20 July, 2022SAHPRA & UK’s Department for International Trade sign MOU
19 July 2022 Johannesburg – The South African Heal
19 July, 2022Health Product literacy top of mind as SAHPRA announces online medicines directory
28 June 2022 The South African Health Products Aut
28 June, 2022SAHPRA’s MOU with SANAS extended
28 June 2022 Pretoria – The South African Health P
28 June, 2022SAHPRA registers the COVID-19 vaccine, Coronavac
Embargo: Immediate release Pretoria, 24 June 2022
24 June, 2022SAHPRA Announces Approval of Breakthrough Treatments for Children with HIV
Embargo: Immediate release Pretoria, 23 June 2022
23 June, 2022SAHPRA’s use of the Med Safety app in the spotlight
23 June 2022 The South African Health Products Reg
23 June, 2022
Learn more about monkeypox as we record first confirmed case in SA
SamuelFrancisJohnson via Pixabay
23 June, 2022The Dynamics of Assuming a New CEO or Leadership Role under Global Lockdown Restrictions
17 June 2022 CEO Perspectives and Horizons as Covi
17 June, 2022SAHPRA registers a vaccine and provides emergency use authorisation of health products in the fight against COVID-19
07 June 2022 Embargo: Immediate release1. The COVI
07 June, 2022SAHPRA statement on the termination of the “Ivermectin Controlled Compassionate Use Access Programme”
30 May 2022 Embargo: Immediate release Pretoria, 3
30 May, 2022Update: SAHPRA Statement on the ANHP Judgement
27 May 2022 Embargo: Immediate release On 7 May 20
27 May, 2022Regulatory 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-Ehrl
17 May, 2022Safety of the COVID-19 Vaccine Janssen – response to restrictions imposed in the United States
12 May 2022 Embargo: Immediate release In both the
12 May, 2022SAHPRA Statement on the ANHP Judgement
EKATERINA BOLOVTSOVA via Pexels
07 May, 2022SAHPRA Comments on ACDP court matter on vaccines for minors
03 May 2022 Embargo: Immediate release Pretoria, 3
03 May, 2022SAHPRA Responds to the ANHP Judgement
20 April 2022 Embargo: Immediate release The South
19 April, 2022SAHPRA CT Office Relocation
08 April 2022 The South African Health Products Re
08 April, 2022SAHPRA Responds to claims that hawkers are selling illicit medication in Cape Town
08 April 2022 Embargo: Immediate release The South
08 April, 2022SAHPRA assigns a non-compliant rating to the Emergent BioSolutions COVID-19 facility
31 March 2022 SAHPRA has assigned a non-compliant
31 March, 2022SAHPRA clarifies the risks and benefits of the Pfizer Comirnaty vaccine
11 March 2022 Embargo: Immediate release The South
11 March, 2022SAHPRA has authorised access to molnupiravir
17 February 2022 Embargo: Immediate release Until
17 February, 2022SAHPRA registers two COVID-19 vaccines
adria Crehuet Cano via Unsplash
07 February, 2022Vaccines – News and updates
7 February 2022 SAHPRA registered the Comirnaty va
07 February, 2022SAHPRA and USP Announce MOU to Advance Regulatory Oversight for Medical Products in South Africa
14 January 2022 Embargo: Immediate release Joint M
14 January, 2022SAHPRA approval of second/booster dose of the COVID-19 vaccine Janssen
23 December 2021 Embargo: Immediate release The So
08 December, 2021SAHPRA approval of booster dosing with the Pfizer (Comirnaty®) COVID-19 vaccine
8 December 2021 Embargo: Immediate release The Sou
08 December, 2021
SAHPRA Office Closure
7 December 2021 Please note that the SAHPRA office
07 December, 2021SAHPRA and the Pfizer Booster (3rd dose) Vaccine
26 November 2021 Embargo: Immediate release SAHPRA
26 November, 2021SAHPRA announces results of onsite inspection at Emergent BioSolutions facility in Baltimore, Maryland
22 November 2021 In June 2021, SAHPRA communicated
22 November, 2021Update on the SAHPRA review of the Sputnik V Vaccine
18 October 2021 SAHPRA has been engaged in a rolli
18 October, 2021Extension of Post Importation Testing Exemptions
30 September 2021 Attention all stakeholders Post
30 September, 2021SAHPRA update on Section 21 authorisation for Pfizer Comirnaty Vaccine
10 September 2021 The South African Health Product
10 September, 2021FDA’s stance on ivermectin aligned to SAHPRA’s position
3 September 2021 The South African Health Products
03 September, 2021SAHPRA’s vaccine registration process and role of the SAHPRA Board
30 July 2021 The South African Health Products Reg
30 August, 2021SAHPRA Statement on Adverse Events Following Immunisation (AEFIs) with COVID 19 VaccineS
20 August 2021 The South African Health Products R
20 August, 2021Health regulatory bodies condemn looting and violence targeting health care facilities
19 July 2021 As South Africa’s statutory health re
19 July, 2021- 13 July, 2021
SAHPRA AUTHORISES THE CORONAVAC VACCINE WITH CONDITIONS
03 July 2021 The South African Health Products Reg
03 July, 2021Media release on the approval process of Covid vaccines
01 July 2021 The South African Health Products Reg
01 July, 2021SAHPRA’s Response to the Economic Freedom Fighters (EFF) March
25 June 2021 The South African Health Products Reg
25 June, 2021SAHPRA and the Sinopharm Vaccine
23 June 2021 SAHPRA has received documentation for
23 June, 2021SAHPRA update on Vaccine Approvals
21 June 2021 The South African Health Products Reg
21 June, 2021SAHPRA update COVID-19 Vaccine Janssen – FDA Developments
13 June 2021 SAHPRA registered the Covid-19 Vaccin
13 June, 2021SAHPRA Represented at A side event at the 30th Commission on Crime Prevention and Criminal Justice
11 June 2021 Background World Health Organization
11 June, 2021SAHPRA update on the COVID-19 Vaccine Janssen – GMP Concerns
7 June 2021 SAHPRA registered the Covid-19 Vaccine
07 June, 2021Section 21 extension (Ventilators – invasive and non-invasive)
07 June 2021 To whom it may concern We draw
05 June, 2021Covid-19 has catapulted Boitumelo Semete- Makokotlela into the public eye
24 May 2021 Boitumelo Semete-Makokotlela’s childre
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 hig
29 April, 2021Extension of Post Importation Testing Exemptions
23 April 2021 Post Importation Testing Exemptions
23 April, 2021SAHPRA 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 la
22 April, 2021SAHPRA Statement – Update on Sisonke Phase 3B Implementation Study
17 April 2021 SAHPRA has engaged with the Sisonke
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
13 April, 2021SAHPRA Statement- High Court Order – Ivermectin
9 April 2021 On 6 April 2021 the Pretoria High Cou
09 April, 2021SAHPRA registers Covid-19 Vaccine Janssen (Ad26.COV2-S [recombinant]) with conditions
01 April 2021 The South African Health Products Au
01 April, 2021SAHPRA has NOT authorised Ivermectin for the treatment of COVID-19
29 March 2021 The SABC placed an erroneous report
29 March, 2021Regulatory stringency and adaptability in the time of COVID-19
25 March 2021 As the entire world ushered in 2020,
25 March, 2021SAHPRA implements a new and improved online submission portal for Section 21 applications
19 March 2021 SAHPRA has implemented a new and imp
22 March, 2021SAHPRA registers Soolantra 10mg/g Cream- An ivermectin formulation
19 March 2021 On 16 March 2021 SAHPRA registered S
19 March, 2021SAHPRA and the Pfizer/Biontech Comirnaty Vaccine
16 March 2021 SAHPRA has approved the Sectio
16 March, 2021SAHPRA clarifies its stance on Ivermectin
03 February 2021 There is an erroneous notion that
03 February, 2021SAHPRA AUTHORISES COVISHIELD – AN ADENOVIRUS-VECTORED VACCINE FOR THE PREVENTION OF COVID-19
27 January 2021 In an effort to enable and support
27 January, 2021SAHPRA OTC ONLINE DIRECTORY
06 January 2021 SAHPRA is pleased to announce the
06 January, 2021Extension of Post Importation Testing Exemptions
22 December 2020 Post Importation Testing Exemptio
22 December, 2020Frequently Asked Questions: New Variant of SARS-CoV-2 in South Africa
19 December 2020 Health Minister Dr Zweli Mkhize o
19 December, 2020INFORMATION AND GUIDANCE ON IMMUNIZATION WITH THE NEW COVID-19 VACCINES
10 December 2020 What is a Covid-19 Vaccine? A COV
10 December, 2020INFORMATION AND GUIDANCE ON APPLICATION FOR REGISTRATION OF CANDIDATE COVID-19 VACCINE
04 December 2020 Coronavirus disease (COVID-19) is
04 December, 2020BACKLOG CLEARANCE NEWSLETTER COMMUNICATION
19 November 2020 The Backlog Clearance Team has be
19 November, 2020HEALTH PRODUCT APPLICATION STATUS CHECKER
SAHPRA has implemented an application status check
03 November, 2020SAHPRA APPROVES SARS-Cov-2 SEROLOGY TEST KITS
Embargo: Immediate release SAHPRA has issued Secti
25 August, 2020COMMUNICATION TO STAKEHOLDERS – COVI-VIG REPORTING SYSTEM
In the interest of public health, SAHPRA has launc
20 August, 2020SAHPRA BACKLOG CLEARANCE PROGRAMME NEWSLETTER
The Backlog Clearance Programme has received appli
11 August, 2020SUBMISSION OF BAU REGISTRATION AND VARIATION APPLICATIONS
Business-As-Usual (BAU) process have been amended
01 August, 2020COMMUNICATION TO INDUSTRY- SCHEDULING STATUS: THC AND CBD
In its 25 November 2019 communication to stakehold
28 May, 2020PHARMACEUTICALS AND VACCINES SUPPLIERS FOR COVID-19 PANDEMIC
SAHPRA and B4SA under the Pharmaceutical and Vacci
09 May, 2020COVID-19 – THE APPROPRIATE PLACE FOR RAPID TEST KITS
In line with the recommendation of the South Afric
30 March, 2020GUIDELINE FOR ADVERSE DRUG REACTIONS (ADRS) REPORTING FOR HEALTHCARE PROFESSIONALS
The document in the link below has been prepared t
28 March, 2020GUIDELINES ON INFLUENZA VACCINATION FOR 2020
The World Health Organisation (WHO) has declared C
26 March, 2020SAHPRA RESPONDS TO CORONAVIRUS (COVID-19): MEDICINES/MEDICAL DEVICES SUPPLY CHALLENGES
The new coronavirus (COVID-19) will continue to ha
17 March, 2020UNODC
SAHPRA represented at the Commission on Narcotic D
28 February, 2020- 04 February, 2020
TOP STORY- INTERVIEW WITH SAHPRA’S NEW CEO
Download PDF
02 February, 2020CODEINE-CONTAINING MEDICINES
SAHPRA- REVIEWING SCHEDULING STATUS OF CODEINE-CON
29 January, 2020IMPORTANT NOTICE – CANNABIS WALK-IN APPLICATIONS
All walk-in clients who want to lodge ap
23 January, 2020CANNABIS SAMPLE APPLICATION FORM
Download PDF
20 January, 2020CANNABIS Q & A
Download PDF
13 December, 2019API NAMES UPDATED TO ALIGN WITH WHO INN
The South African Health Products Regulatory Autho
02 August, 2019WHO OR WHAT IS SAHPRA
10 May 2019 SAHPRA is the South African Health Pro
10 May, 2019
