Applicants are hereby notified that the South African Health Products Regulatory Authority (SAHPRA) Engagement Portal is set to launch at midday on 01 April 2025....
This communication serves to notify applicants about the issuance of Application IDs. Following the administrative freeze (ending 31 March 2025), newly generated Application IDs will be available on the portal for each application, encompassing all strengths and multiples combined. In accordance with eCTD Specification 3.1,...
This communication aims to provide an update to applicants regarding a South African Health Products Regulatory Authority (SAHPRA)-initiated grace period for cancelling the registration of health products not in eCTD format. Post the implementation of the eCTD 3.1 submissions process, SAHPRA has started to receive communication...
This communication is issued given the current uncertainty about US government funding for healthcare in South Africa, particularly in clinical research, and it intends to emphasise the responsibilities of various stakeholders in Clinical Trials....
This document is intended to communicate the South African Health Products Regulatory Authority’s (SAHPRA’s) position to all applicants/Holders of Certificates of Registration (HCRs) who intend to submit/have submitted applications supported by bioequivalence studies conducted by Synapse Labs Pvt. Ltd, a Contract Research Organisation (CRO) located...
SAHPRA intends to declare medicines compounded in terms of Section 14(4) of the Medicines Act containing Glucagon-Like Peptide-1 (GLP-1) Active Components or a combination of Glucagon-Like Peptide-1 (GLP-1) and Gastric Inhibitory Polypeptide agonist (GIP) Active Components undesirable in terms of Section 23 of the Medicines...
Reference is made to HPA15-2024/25, version 5 and version 6. This document serves to inform applicants about the upcoming launch of the SAHPRA Engagement Portal on 01 April 2025. SAHPRA wishes to thank applicants for the validation of data points and to re-iterate the significance of the...
This document is intended to provide clarification on the fees payable in terms of the Medicines and Related Substances Act, 101 of 1965, that have been gazetted on 12 February 2025 for applications for the renewal of the certificate of registration....
This document is intended to provide communication to updated Regulations Regarding Fees Payable in Terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965) have been gazetted on 12 February 2025 introducing a new fee dispensation....
This document is intended to provide communication on the revised Regulation Regarding Fees Payable in Terms of the Medicines and Related Substances Act, 1965 (Act No. 101 of 1965)....