Communication to industry Archives - Page 7 of 22

01 Apr SAHPRA Engagement Portal – Application IDs

Posted at 10:11h in

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,...

12 Mar Regulatory Information Management System – Cancellation of Health Product Registrations for non-eCTDs

Posted at 09:37h in

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...

10 Mar Clinical Trials Conduct – USA Government Funding Pause/stop

Posted at 10:33h in

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....

10 Mar Comm Issue No.PEM01-CEM01-2025 – Bioequivalence studies performed by Contract Research Organisation (Synapse Labs Pvt. Ltd)

Posted at 09:27h in

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...

10 Mar Communication to Industry – Intention to Declare Medicines Compounded in terms of Section 14(4) Containing GLP-1or GLP-1/GIP Agonists Undesirable

Posted at 08:32h in

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...

27 Feb Implementation of the Regulatory Information Management System– Status updates on the SAHPRA Engagement Portal

Posted at 09:48h in

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...

19 Feb Fee Schedule and Explanatory Notes – Renewal of the Certificate of Registration

Posted at 14:12h in

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....

12 Feb Newly Gazetted Regulation Regarding Fees Payable in Terms of the Medicines and Related Substances Act

Posted at 18:52h in

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....

07 Feb Revised Fees Regulation Update

Posted at 17:04h in

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)....

30 Jan Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix

Posted at 09:28h in

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...

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