Archive

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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23 Jul Communication to Industry – FAQs on Active Pharmaceutical Ingredient

Posted at 14:07h in

This FAQs document is intended to provide communication to the API suppliers to assist them with adequately addressing the most common queries received by SAHPRA....

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23 Jul Frequently asked questions (FAQs) and common deficiencies for the submission of PEM Post-Registration variations

Posted at 10:43h in

This guidance represents the current thinking of the SAHPRA on this topic. It does not establish any rights for any person and is not binding on SAHPRA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes...

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23 Jul CTD Checklist

Posted at 10:39h in

The checklist must be included in submissions that include variations for CTD conversions. This checklist should also be included as an annexe to the cover letter for the baseline sequence when converting from eSubmission to eCTD....

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