Archive
13 Oct Certification Variation Screening – Type II Proprietary name change applications and TOA’s
Posted at 11:06h
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The certification unit is processing a large number of applications with administrative queries, which then results in the delay of generating the revised registration certificate. The unit will be introducing a pilot to include administrative screening on receipt of all certification variation applications. The revised...
10 Oct Position Paper – Proposal to Applicants for Dossier Processing Fee (ZaZiBoNa)
Posted at 17:06h
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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
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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
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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
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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
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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
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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
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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
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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. ...