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14 Apr

Posted at 15:13h in

These guidelines provide recommendations for manufacturers seeking to submit Plasma Master Files to support the quality of the starting materials for Plasma-Derived Medicinal Products (PDMP). These apply to applications for the registration or variations of PDMP. These guidelines emphasise the South African Health Products Regulatory...

01 Apr

Posted at 14:01h in

The South African Health Products Regulatory Authority (SAHPRA) launched the Online Medicines Directory for over-the-counter (OTC) medicines in June 2022. The platform, available at www.medsinfo.sahpra.org.za, serves as a single, trusted source of information for patients, consumers, and healthcare professionals on all medicines approved by SAHPRA. Phase...

31 Mar

Posted at 14:54h in

This guideline specifies the basic security conditions for obtaining a transport authority for Group IV hazardous substances as defined in the Hazardous Substances Act 15 of 1973, referred to in this guideline as radioactive material. This represents the guidance of the South African Health Products...

30 Mar

Posted at 09:11h in

This document has been prepared as a guideline for preparing applications to conduct clinical trials in South Africa. It represents the South African Health Products Regulatory Authority’s (SAHPRA) current thinking on pregnancy and lactation for clinical research in South Africa. It is not intended as...

27 Mar

Posted at 14:53h in

This document has been prepared to serve as a guideline to clarify the requirements of insurance for those who conduct interventional clinical trials involving human participants and intend on making a submission for approval of a clinical trial by South African Health Products Regulatory Authority...

26 Mar

Posted at 15:05h in

This guideline is intended to provide guidance on obtaining a Certificate of Free Sale, which serves as confirmation that the listed medical devices, including in vitro diagnostic medical devices (IVDs), are legally sold or distributed in the market in South Africa, freely without restriction. It...

25 Feb

Posted at 11:36h in

This guideline outlines the principles and procedures for reliance-based review in both premarketing and post-marketing regulatory activities for medical devices, including in vitro diagnostics (IVDs). It defines the Regulatory Reliance pathways that the South African Health Products Regulatory Authority (SAHPRA) will use in making regulatory...