Communication to industry Archives - Page 10 of 23

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....

14 Oct Clinical Trials Committee Meeting and Submission Dates for 2025

Posted at 11:54h in

This communication is for Stakeholders to be aware of SAHPRA's Clinical Trials Committee meeting dates and the submission dates for the year of 2025. ...

11 Oct Communication to Industry – Request for Scientific Information on Yohimbine Use in Veterinary Medicine

Posted at 11:08h in

This communication is intended to seek stakeholder input in gathering scientific information regarding the use of yohimbine in veterinary medicine....

25 Sep Clinical Trial Applications – Investigational Product Import Licence

Posted at 09:33h in

This communication is intended to provide guidance to Applicants about investigational product import licences (clinical trial approval letters) that have been approved by the Department of Health (Medicines Control Council - MCC)....

17 Sep Communication to Industry – Policy Position of SAHPRA on Enabling Local Manufacture

Posted at 20:26h in

Policy Position of SAHPRA on Enabling Local Manufacture
SAHPRA as an organ of state and a public entity is required to align itself with the national imperatives to support the national response in public health emergencies through supporting local manufacturers of health products.
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13 Sep Mpox Diagnostic Tests

Posted at 14:45h in

This communication is intended to provide an update to industry stakeholders concerning Mpox (formerly monkeypox) diagnostic tests in South Africa....

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...

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...

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....

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

Posted at 10:43h in

This communication provides guidance which represents the current thinking of the South African Health Products Regulatory Authority (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...

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