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)....
This document is intended to provide an update on the document matrix to be utilised by all applicants submitting applications for the Renewal of the certificate of registration from 22 January 2025. The Document Matrix location is as follows: https://ectd.sahpra.org.za/ Reference is made to ZA-SAHPRA eCTD...
This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines. Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...
This communication is intended to provide an update to applicants on the process for the cancellation of registered health products in Specification 3.1 and as of 01 November 2024. Reference is made to ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information, July 2024,...
