News and Updates

SAHPRA TV and Podcasts

Stay up to date with our latest news, media coverages, interviews and announcements on SAHPRA TV.

LICENCES AND REGISTERS

MEDSAFETY and AEFI reporting microsites

These microsites prvoide information on how to report adverse events as well as latest reports of adverse events following immunisation (AEFIs) associated with COVID-19 vaccine administration.

Safety alerts

SAHPRA Whistleblower

The SAHPRA hotline has been established with the aim of enhancing an honest work ethic and simultaneously providing the public with a mechanism to bring any unethical business practices to the attention of management.

PRODUCT RECALLS

Champix 0,5 mg and 1,0 mg (varenicline) film coated Tablets – combo

Following Test results that indicated levels of increased N-nitroso-varenicline that exceed the Acceptable Daily Intake (ADI) threshold of 733 ng/day calculated by Pfizer, based on ICH M7 guidance, Pfizer Laboratories (Pty) Ltd in South Africa took the decision to initiate a voluntary recall on Champix, batch 18069 and notified SAHPRA Regulatory Compliance Units. Recall process: Recall letter distributed to all healthcare professionals via medpages.

ZAARIO 50 and ZAARIO 100 film coated Tablets (lorsatan potassium)

The products are being recalled due to quality defect: the presence of a mutagenic impurity above the threshold limit observed during analysis, as requested by the European Directorate for the Quality of Medicines and Healthcare (EDQM) on new Azido impurities [the presence of Azido (5-AMBBT) mutagesic impurity beyond total threshold limit was observed during analysis].

Clonam 0.5 mg and Clonam 2 mg film coated Tablets (clonazepam)`

The products are being recalled due to quality defect: the tablet description should be cross-scored, but instead the tablet has only a single score.

UPCOMING AND PAST EVENTS

Stay up to date with SAHPRA’s upcoming, and past recorded events.

SOCIAL MEDIA FEEDS

1 month ago

We're Hiring!

We’d like to talk to you if you are qualified for the below vacancies:
1. Two PORTFOLIO COORDINATORS: PHARMACOVIGILANCE
2. MEDICAL OFFICER: SECTION 21 AUTHORISATIONS
3. Three ... See more

2 months ago

We're Hiring!

We’d like to talk to you if you are qualified for the below vacancies:
1. 2(TWO) INSPECTORS: GVP
2. MEDICAL OFFICER: SECTION 21
3. INSPECTOR: GCP

To learn more and apply: ... See more

Webinar recording - Launch of SAHPRA’s Online OTC Medicines’ directory [Thread]

South African Health Products Regulatory Authority (SAHPRA) hosted a live webinar launching our new and first-of-its-kind Online Directory for over-the-counter (OTC) medicines in South Africa.

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