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South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS

Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For ECTD Variation Applications", For "Module 2.3 Quality Overall Summary (QOS)" and "For Module 2.3 Quality Information Summary (QIS)".

SAPHRA’s Validation Template For ECTD Variation Applications is a document that provides guidance on how to validate electronic submissions of variation applications for human medicines in South Africa.

An application's Validation Template allows SAHPRA to verify that all required information has been provided when evaluating a variation application submitted in eCTD format for a medicinal product for human use. It contains information on the validation criteria, the validation process, the validation report, and the validation checklist.

It is also used for follow-up sequences that may be required for the variation and the applicant must ensure that all relevant fields are completed.

The implementation date is 15 May 2023.

Similar to the validation template, Module 2.3 Quality Overall Summary (QOS) document is for use in all products including Biologics and veterinary products, where the information is not applicable for the specific molecule it is suggested to indicate “N/A” and Module 2.3 Quality Information Summary (QIS) should be completed to provide a condensed summary of the key quality information for applications containing APIs of synthetic, semi-synthetic or biological origin.


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