Have a look at this infographic that Extedo® and Asphalion have prepared with the summary updates in terms of publishing and eSubmission at a regional level. This month we are focusing on South Africa!
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. We can support you in a variety of activities.
Please complete the form in order to get the link to the free downloadable infographic here: