Do you need to ‘Trigger’ an eCTD solution? Helping finger is at hand!
SAHPRA is in the process of streamline the review process for eCTD format regulatory dossier submissions. This involves an upgrade from eCTD version 2.1 to version 3.0 with changes in the South African regional section and the introduction of an internet portal. It promises significant benefits for regulatory ‘Applicants’.
This change is taking place over the period 2024-04-16 to 2024-07-01 when SAHPRA’s new internet portal is scheduled to launch and 2024-10-01 which is the scheduled cut-off date for eCTD dossiers and dossier amendments in the 2.1 format.
During this transition eCTD 2.1 format submissions have to include an additional file containing the more detailed submission classification information SAHPRA requires for the new streamlined review process. SAHPRA describes this xml format file as a ‘Trigger’ file.
To facilitate this SAHPRA have published an Excel spreadsheet on their web site that allows users unfamiliar with the xml markup language to create the ‘Trigger’ file using Excel.
In order to facilitate the production of the ‘Trigger’ file by any of its clients who may be challenged by this sophisticated spreadsheet, Quad Pharma has developed a simple app to create the Trigger file. It is called ‘eQALs Trigger’.
‘eQALs Trigger’ is easy to use and is fully documented with a comprehensive ‘Help’ function. It is easily installed on Windows PCs. It is also available free of charge to any pharmacists involved in medicines registration.
To get your free personal copy simply email your request to robin@eqals.co.za or info@quadpharma.com .
You can also download it from the Quad Pharma website.