Archive

30 Jan Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1 – Document Matrix

Posted at 09:28h in

This document is intended to provide an update on the document matrix to be utilised by all applicants submitting applications for the Renewal of the certificate of registration from 22 January 2025. The Document Matrix location is as follows: https://ectd.sahpra.org.za/   Reference is made to ZA-SAHPRA eCTD...

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28 Jan Update: Phenylephrine – Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Posted at 20:41h in

This document is intended to communicate with the Holders of Certificates of Registration (HCRs) of orally administered phenylephrine-containing medicines.   Following the communication issued to stakeholders on 30 July 2024 regarding the ineffectiveness of oral phenylephrine preparations as nasal decongestants, HCRs for orally administered phenylephrine-containing medicines were...

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22 Jan Regulatory Information Management System – Application Withdrawal

Posted at 11:40h in

This communication is intended to provide an update to applicants on the process for the cancellation of registered health products in Specification 3.1 and as of 01 November 2024. Reference is made to ZA-SAHPRA eCTD Specification and Guidance for Module 1 and Regional Information, July 2024,...

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11 Nov Quality Variations

Posted at 15:17h in

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...

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07 Nov SAHPRA Engagement Portal

Posted at 14:22h in

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....

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29 Oct Implementation of Regulatory Information Management System – Information on eCTD 3.1 Module 1 – Document Matrix

Posted at 10:08h in

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....

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25 Oct Communication to Industry – Implementation of RIMS – Information on eCTD 3.1 Module 1

Posted at 15:07h in

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....

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20 Aug Sameness Declaration Form for Reliance-based Models

Posted at 16:24h in

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01 Aug Phenylephrine Lack of Effectiveness of Oral Preparations as Nasal Decongestant

Posted at 14:17h in

This document is intended to provide communication to the HCRs for orally administered phenylephrine-containing medicines.   The Advisory Clinical Committee discussed the communication from the United States Food and Drug Administration (US-FDA) regarding the efficacy of orally administered phenylephrine as a nasal decongestant. This communication emanates from...

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01 Aug Restriction on Codeine Use in Children, Pregnant and/or Breastfeeding Mothers

Posted at 14:14h in

This document is intended to provide communication to The Holder of Certificate of Registration for Codeine containing products.   The Advisory Clinical Committee (ACC) reviewed data submitted by HCRs to support the continued use of codeine in children under 12 years and concluded that there is evidence...

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