Communication to industry Archives - Page 16 of 24

10 Oct Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)

Posted at 17:06h in

Position Paper
Proposal to Applicants for Dossier Processing Fee - SADC MRH Collaborative Registration Procedure Initiative - A stepwise approach to increased efficiency and effectiveness

As the initial step to improve efficiency, the SADC Medicines Regulators Forum is proposing a semi-centralised approach to the joint...

20 Sep Over-arching: Good Review Practice Guide

Posted at 10:10h in

This guide is intended to provide guidance to applicants on Good Review Practices. It represents the South African Health Products Regulatory Authority’s current thinking on the safety, quality and efficacy of medicines and the safety, quality and performance of medical devices. It is not intended...

08 Sep Extension on commentary period for Borderline Products Guideline

Posted at 09:23h in

Please note that the South African Health Products Regulatory has hereby extended the deadline date for comments on the Borderline Products guideline (SAHPGL-CRO-01) from the 5th of September 2022, to the 8th of November 2022....

30 Aug Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators

Posted at 10:01h in

In response to the anticipated shortage of medical supplies and equipment in the health care system as a result of the outbreak of the Covid-19 pandemic, the South African Health Products Regulatory Authority (the Authority) published minimum requirements for the manufacture, importation, and distribution of...

29 Aug Missing Applications – Call to Industry

Posted at 08:49h in

Business-As-Usual (BAU) is in the process of verifying submitted/received new medicine and variation applications. Industry is kindly requested to verify/confirm if all the applications that have been submitted to SAHPRA via BAU are being processed....

12 Aug SAHPRA Digital Transformation – Deployment of a Stakeholder portal

Posted at 17:24h in

In keeping with SAHPRA’s strategic objectives – Digital Transformation has been a key focus are for SAHPRA ICT....

08 Aug Electronic Submission Of Adverse Drug Reaction (ADR) Reports – E2b Reporting

Posted at 14:04h in

For over a decade, ADR reports have been submitted to the National Adverse Drug Events Monitoring Centre (NADEMC) via fax. These reports were previously captured on the ADRI database. The ADRI database restricted electronic reporting by both applicants and healthcare professionals, and direct uploading of...

02 Aug Expression Of Interest: SADC Medicines Regulatory Worksharing, Zazibona Collaborative Process

Posted at 10:01h in

In an effort to encourage widespread access to medicines in the Southern African Development Community (SADC) region, SAHPRA invites applicants to submit Expressions of Interest (EOIs) for evaluation of applications through the Zazibona collaborative process. ...

15 Jul COVID-19 Test Kits Batch Verification

Posted at 12:45h in

The COVID-19 pandemic is caused by SARS-CoV-2, a novel coronavirus that originated in Wuhan, China in late 2019. The virus has since spread around the world, with novel variants of concern causing new waves of infection. Testing is a critical component of COVID-19 control and...

22 Jun Communication to Industry on Nitrosamine Review for New Applications and Registered Products including Biologicals

Posted at 13:23h in

This document is intended to provide communication to industry on nitrosamine review for all other new, in-process and registered products including biological medicines and all old medicines. This will be a “living document” and will be updated. It is important that Applicants adhere to the...

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