This document is intended to provide communication to the HCRs for orally administered phenylephrine containing medicines regarding the Authority's intent to classify these medicines as undesirable due to concerns about their efficacy....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
The communication is directed at applicants or holders of certificates of registration (HCRs) using Synapse Labs Pvt. Ltd to conduct their bioequivalence (BE) studies. It provides information on deficiencies detected by the European Medicines Agency regarding critical deficiencies for BE studies conducted by Synapse Labs Pvt....
The South African Health Products Regulatory Authority (SAHPRA) is a statutory body established in terms of Section 2 of the Medicines and Related Substances Act, 101 of 1965, as amended. The objects of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection,...
MPXV molecular test kit/s that have not been listed, registered or authorised for use in a jurisdiction recognised by the South African Health Products Regulatory Authority (SAHPRA) or that have not been pre-qualified by the World Health Organisation (WHO) will be screened against the minimal...
The first human case of Mpox was reported in the Democratic Republic of Congo; the outbreak has since spread to other countries, including South Africa. South Africa is currently experiencing an outbreak of Mpox clade II. Mpox (previously known as Monkeypox) is an infectious disease...
This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa. The regulatory requirements for Mpox diagnostics can be found in Communication to Industry: Issue No.: MD01-2024/25 v1...
The international standard ISO 13485 (ISO 13485:2016 Medical Devices - Quality Management Systems – Requirements for regulatory purposes) for a quality management system (QMS) is recognised globally to address minimum regulatory requirements for medical devices and in vitro diagnostics (IVDs). The standard outlines the requirements...
This document intends to communicate to all the users of Group III and IV hazardous substances about the processes of sealing and unsealing the equipment. The sealing of dangerous substances is an enforcement action and may occur during announced and/or unannounced inspections or in the...