Communication to industry Archives

15 May SAHPRA Warning About Unregistered Peptide Products: What You Need to Know and How To Stay Safe

Posted at 14:51h in

SAHPRA is seeing an increase in unregistered peptide products being sold online, in gyms, and through informal channels. Because these products have not been evaluated and approved by SAHPRA for safety, quality, or efficacy, they can seriously harm your health. If you are unsure about...

07 May Bioequivalence studies performed by Contract Research Organisation (Raptim Research Pvt. Ltd)

Posted at 18:49h 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 Raptim Research Pvt. Ltd, a Contract Research Organisation...

20 Apr SAHPRA Clinical Trials Online Applications Platform

Posted at 10:30h in

Following the launch of the online applications form for CTF1 on the 7th of April and the constructive engagement on 13 April 2026, several enhancements discussed have now been implemented to improve the user experience. All enhancements went live this morning, enabling us to more...

16 Apr Variations Communication

Posted at 16:10h in

The South African Health Products Regulatory Authority (SAHPRA) notifies all applicants that Type II Variations Pilot submission window has been extended from 21 April 2026 to 30 April 2026....

10 Apr Licensing Requirements for Outsourced or Contracted Activities for Medical Device Establishments

Posted at 13:10h in

This is intended to provide stakeholders with guidance and the requirements for medical device (including In Vitro Diagnostics (IVDs)) manufacturers, distributors and wholesalers who appoint or contract a third party to perform manufacturing, distribution or wholesaling activities on their behalf, for the purpose of placing...

01 Apr Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant: Extension of Deadline for Written Submissions and Updated Meeting Date

Posted at 21:20h in

The South African Health Products Regulatory Authority hereby issues an update to all Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines, following the communication dated 23 March 2026. Download previous version ...

01 Apr E2B Standard as Acceptable Method of Reporting SAEs Occurring During Clinical Trial Conduct to SAHPRA

Posted at 16:02h in

This document is intended to provide communication to various stakeholders conducting Clinical Trials on allowed method for Serious Aderse Events (SAE) reporting to SAHPRA....

31 Mar Medical Devices Registration Feasibility Study report

Posted at 15:01h in

The purpose of the Medical Device Registration Feasibility Study was to support the South African Health Products Regulatory Authority (SAHPRA) in advancing the implementation of a comprehensive regulatory framework for medical devices, including in vitro diagnostics (IVDs), within South Africa. The study aimed to evaluate...

30 Mar SAHPRA Advisory on the Use of Unregistered Veterinary Products

Posted at 14:43h in

This document is intended to provide communication to all veterinarians and Veterinary Institutions in the Republic of South Africa to reinforce the importance of compliance with national legislation regarding the use of unregistered veterinary medicines. As stewards of animal health and welfare in South Africa,...

27 Mar Variations Communication

Posted at 11:34h in

This notice provides an update to industry regarding Type II variation pilot submission windows....

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