Attn: Board/Committee Members/Evaluators: Please take note of the dates for submission of claims for the remainder of the 2024/25 financial year....
This document is intended to provide Communication to Industry on post-registration quality variation general announcements and submission of exception codes. The document contains information that the applicant should consider when submitting applications for review. This document includes general information applicable to application submissions and exception codes...
As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we have launched the SAHPRA Engagement Portal on Monday, 04 November 2024. The first phase of the phased roll-out is to have all users start the User Account creation process....
This document is intended to provide an update on the document matrix to be utilised by all applicants from 01 November 2024 (eCTD 3.1 go-live date). The Document Matrix location is as follows: ectd.sahpra.org.za....
This document is intended to provide an update on the progress for the Regulatory Information Management System (RIMS) deployment. In the development of the new eCTD specifications, attention has been given to global best practice and the frameworks and specifications from other Recognised Regulatory Authorities....
This communication is for Stakeholders to be aware of SAHPRA's Clinical Trials Committee meeting dates and the submission dates for the year of 2025. ...
This communication is intended to seek stakeholder input in gathering scientific information regarding the use of yohimbine in veterinary medicine....
This communication is intended to provide guidance to Applicants about investigational product import licences (clinical trial approval letters) that have been approved by the Department of Health (Medicines Control Council - MCC)....
Policy Position of SAHPRA on Enabling Local Manufacture
SAHPRA as an organ of state and a public entity is required to align itself with the national imperatives to support the national response in public health emergencies through supporting local manufacturers of health products.
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This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa....