Normal submission of Type IA & IAIN, IB, II The South African Health Products Regulatory Authority (SAHPRA) allows for variation submissions as follows: Type IA variations (inclusive of Type IAIN): a maximum of three (3) type IA variation changes (unrelated or related) is applicable for a...
The Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, read in conjunction with the General Regulations on Medical Devices, published in Government Gazette Notice 40480, No.1515 of 9 December 2016, provides for the regulatory oversight of veterinary medical devices including In-Vitro...
The South African Health Products Regulatory Authority (SAHPRA) has issued important updates impacting the technical files located in the SAHPRA eCTD repository and found in the following location, SAHPRA eCTD....
This communication to industry was developed to express SAHPRA’s view that the therapeutic use of yohimbine in animals may be in the public interest and to outline the steps that SAHPRA is taking to place the product in the schedules....
The South African Health Products Regulatory Authority (SAHPRA) provides the following key updates on the SAHPRA Engagement Portal....
This document is intended to provide communication to the HCRs for orally administered phenylephrine containing medicines regarding the Authority's intent to classify these medicines as undesirable due to concerns about their efficacy....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
The South African Health Products Regulatory Authority (SAHPRA) is providing key updates on the SAHPRA Engagement Portal....
The communication is directed at applicants or holders of certificates of registration (HCRs) using Synapse Labs Pvt. Ltd to conduct their bioequivalence (BE) studies. It provides information on deficiencies detected by the European Medicines Agency regarding critical deficiencies for BE studies conducted by Synapse Labs Pvt....
The South African Health Products Regulatory Authority (SAHPRA) is a statutory body established in terms of Section 2 of the Medicines and Related Substances Act, 101 of 1965, as amended. The objects of the Authority are to provide for the monitoring, evaluation, regulation, investigation, inspection,...