SOUTH AFRICA | SAHPRA submissions

In 2013, the South African authority SAHPRA started accepting submissions in eCTD format for pharmaceuticals.

In 2013, the South African authority SAHPRA started accepting submissions in eCTD format for pharmaceuticals.
November 2, 2022

Have a look at this infographic prepared by Extedo® and Asphalion with the summary updates in terms of publishing and eSubmission at a regional level. On this occasion, we are focusing on Taiwan!

In 2013, the South African authority SAHPRA started accepting submissions in eCTD format for pharmaceuticals. In 2020, SAHPRA updated section 3.2.R with new titles, but no update of the specification and eCTD structure. The previous titles can still be used in eCTD submission.

ASPHALION and our partner Extedo® can guide you with the transitions in South African eCTD submissions, and we can support you in a variety of activities.

You can dowload the document here:

SOUTH AFRICA SAHPRA Infographic

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