TGA and Electronic Submissions
Regulatory Affairs Departments worldwide are known for the huge amount of paper accumulated and the correspondingly large amount of space used to store it.
Applications for new products to TGA can run into hundreds of volumes, using many thousands of sheets of paper, all of which TGA must store for decades.
But due to electronic systems that store and transmit large amounts of information conveniently and inexpensively, and environmental and cost concerns associated with using large amounts of paper, regulatory agencies everywhere are moving to allowing (and in some cases requiring) electronic regulatory submissions.
TGA going electronic
TGA requires electronic copies on disc, but still needs paper copies. Draft guidelines show it is committed to introducing electronic-only submissions, but it appears paper applications will be required for a while yet.
TGA is, however, working with evaluators (both internal and external) to train them in the use of electronic dossiers for evaluation. This represents a significant change from evaluating paper copies. Many evaluators are finding it difficult to change their work practices from having multiple hard copy volumes open on their desks to cross-referencing multiple PDF files on their computer desktop.
How readily evaluators adopt this change depends on whether electronic dossiers are easy to use, and how readily TGA IT infrastructure will allow evaluators to access information while also completing their reports.
The e-dossier
So what can industry do to ensure high quality electronic dossiers that are easy to evaluate?
TGA now requires submission of electronic applications in the non-eCTD electronic submission format (NeeS). This uses the same granularity folder structure as the eCTD, but lacks the XML backbone of the eCTD.
The NeeS has specific requirements for folder structure and folder and file naming, and it should be ensured that these are followed. A number of tools are available to assist, and folders with no content are not required and should be deleted.
Navigation and search
The dossier should be easy to navigate and include hyperlinked tables of contents, bookmarks for each document and, preferably, the ability to go back to previous levels.
If possible, all dossier text should be searchable to assist in locating information. PDF documents that are merely scans of documents cannot be searched and make evaluation difficult.
Searchable text also assists the evaluator by enabling it to be cut and pasted for inclusion in the evaluation report. Some documents (such as certificates of analysis) are difficult to make searchable, but can be made easy to locate via searchable title pages linked to the table of contents.
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