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

Search News & Events

  • Filter by category

Share

Related news and events

US FDA | SD File

The SDF is an extensible, portable text file encoding computer-readable chemical structures linked to associated data fields. Is also commonly called an SD File or

FDA Study data

Are you planning to send a submission to the FDA? Will this submission contain study data? If the answer to these 2 questions has been

Taiwan TFDA Infographic

Have a look at this infographic that Extedo® and Asphalion prepared with the summary updates in terms of publishing and eSubmission at a regional level.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting