South America is still taking its first tentative steps toward the standardization of submission dossier formats for registered medicinal products. Most countries within the region have their own local format; some allow information to be submitted electronically on their local portals.

The country is leading the charge in Brazil, the only Latin American representative within the ICH. After joining the ICH as a regulatory member in November of last year, Brazil adopted the CTD format for some regulatory areas. Going forward, it will be mandatory for all submissions by 2021. Some departments within ANVISA already accept dossiers in CTD format. However, as an interim step, by June this year, all submissions sent to ANVISA will need to be in an electronic format.

The eCTD standard is now used extensively within Europe and the US and is gradually being rolled out by other regulatory agencies worldwide. As this roll-out continues, organizations need to prepare themselves for the new way of working. This will mean additional effort in the short term, but by ensuring that software is updated and processes optimized businesses can best take advantage of the opportunities that eCTD provides.

In the meantime, as we wait for the eCTD format to become a reality within South America, you can still use eCTDmanager to create electronic submissions and even paper via the non-eCTD option. eCTDmanager allows you to create any submission type with any specific folder hierarchy you designate.

Using eCTDmanager, all submissions are stored in one single place and are easy to navigate. Links to all the documents within the index are automatically created by eCTDmanager. This way, the information is not lost, and all documentation is well-tracked.


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