Archive

26 Jan Clinical Trials Committee and Submission dates for 2022

Posted at 13:43h in

To all Applicants: Kindly note that COVID-19 Clinical Trial Applications do not follow the above predetermined submission due dates. They can be submitted to SAHPRA at any time. The last COVID-19 CTC meeting for 2022 is on the 09 December 2022 and the submission due...

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25 Jan Section 21 Access to Unregistered Medicines – IVERMECTIN CONTROLLED COMPASSIONATE USE PROGRAMME

Posted at 13:18h in

Given that there is currently no credible evidence to support a therapeutic role for Ivermectin in COVID-19, SAHPRA has decided to terminate the Programme with immediate effect.

Archive

Ivermectin Controlled Compassionate Use Programme

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25 Jan Guidance Rapidly developed ventilator

Posted at 12:59h in

2020 May...

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25 Jan Extension – Use of acknowledgement letter in lieu of a licence

Posted at 12:54h in

2020 Mar...

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25 Jan Re-submission of BAU New Medicines Applications from 2018 and 2019

Posted at 10:42h in

This document has been archived....

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25 Jan Pilot: BAU new medicine applications for registration

Posted at 10:40h in

This document has been archived....

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25 Jan eCTD Implementation roadmap communication

Posted at 10:38h in

This document has been archived.

Archives

Download Version 2 (9.127)

Date updated

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25 Jan BAU Variations Communication

Posted at 10:36h in

This document is intended to provide communication to applicants wishing to submit variations to existing registrations. This will be a “living document” and will be updated. Kindly note that this is an interim document and that the information will be incorporated into a General Information...

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25 Jan Industry Communication on Interim Measures Pending Update of Variation Addendum

Posted at 09:58h in

2020 Sep...

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24 Jan Reflection document on regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2

Posted at 12:37h in

This document has been archived....

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