This communication is for Stakeholders to be aware of the South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting dates and the submission dates for the year of 2024. ...
This communication to industry refers to the Medical Device Unit and Radiation Control Unit publishing SAHPRA’s position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746....
Please be informed that all documents and queries for GMP and CPP certificates should now be emailed to a new dedicated email address - see download. ...
We have in the past few weeks assisted several applicants that reached out to us, to retrieve old variations records attached to users that have been de-activated at an organisational level and we thought it best to issue this advice....
Your attention is drawn to the provisions of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) as amended, making provision for the payment of retention fees to the Regulatory Authority in respect of medicines, medical devices and IVDs registered and site licences...
Stakeholders are hereby invited to provide comments to the draft SAHPRA’s Broad-Based Black Economic Empowerment Policy for issuance of new and the renewal of licences as per section 22C of the Medicines Act....
In response to the Supreme Court of Appeal (SCA) judgment on 11 April 2022 regarding the Alliance of Natural Health Products (ANHP), the Minister of Health recently released, for public comment, draft amendments to the General Regulations made in terms of the Medicines and Related...
This document sets out to serve as a notification to all stakeholders on the status of the Health Products Medicines Register. This is a "living document" and will be updated as required. This communication is an interim document....
This document is intended to provide guidance to stakeholders on the use of the newly implemented QOS and QIS....
Please note that SAHPRA will continue to communicate registration certificates for both new medicines and relevant type || variation applications via e-mail to applicants until further notice....