This communication is intended to provide guidance to Applicants about investigational product import licences (clinical trial approval letters) that have been approved by the Department of Health (Medicines Control Council - MCC)....
Novartis, during its portfolio review (Tegretol S® oral suspension included) observed the possibility of exceeding defined permitted daily exposure (PDE) when the product is taken above 1200 mg/day in adult patients because of the quantity of sorbitol in the formulation. Sorbitol is one of the...
Policy Position of SAHPRA on Enabling Local Manufacture
SAHPRA as an organ of state and a public entity is required to align itself with the national imperatives to support the national response in public health emergencies through supporting local manufacturers of health products.
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This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa....
The DHCP letter is intended to inform healthcare professionals about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines. Pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or...
The DHCP letter is intended to inform healthcare professionals about the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) associated with the use of pseudoephedrine-containing medicines. Pseudoephedrine-containing medicines are contraindicated in patients with severe or uncontrolled hypertension, or with severe acute or...
SAHPRA's Annual Report allows for transparency, accountability, as well as a comprehensive view of the entity’s performance and strategic direction....
This Annual Performance Plan (APP) for the 2024/25 financial year that has been developed by SAHPRA, represents the planned actions of the Board of SAHPRA to ensure that through their considered and responsible actions, they can, together with the staff at the Authority, assure and...
This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines. The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...