Electronic data requirements for Category 3 application dossiers
Notification of the TGA's intention to require an electronic copy of Category 3 application dossiers
Data for Category 3 applications is currently required to be submitted to the TGA in paper (hard) copy form; provision of an additional electronic copy is currently optional.
This is to notify sponsors of TGA's intention to require an electronic copy of Category 3 application dossiers in addition to the current requirement for a paper copy. This requirement will also apply to safety-related requests made under section 9D(2). Electronic copies of data for these types of requests were previously required when they were administered as Category 1, Type J applications prior to the changes to processes for making minor variations to prescription medicines.
A summary of the changes applicable to Category 3 applications and safety related requests with data is as follows. Please see the text below under Details for further information.
- For applications submitted from 1 January 2014, we ask that dossiers currently provided in paper form are, in addition, also provided in electronic form, either on a CD or DVD. The provision of electronic dossiers (as well as the paper copy) prior to this date is strongly encouraged.
- For electronic data, CTD format is preferred, however, if this is not possible, the files on the CD or DVD may be organised in any logical format provided the files have been created using commonly used software, are readable, and are labelled in accordance with the naming convention used for the paper copy files.
TGA anticipates that the request for an electronic copy of the dossier for Category 3 applications will not have a substantial time or financial impact on industry, since there is no strict formatting requirement at this time and much of the data to be supplied to the TGA will already exist in electronic form. Electronic copies of data for safety related requests (with data) were previously required when these applications were administered as Category 1, Type J.
If you have any comments or feedback on the above, please provide these to the TGA by email to the Application Entry team by 31 July 2013.
The submission of dossiers in electronic form (CD or DVD) and in paper form is currently a requirement for Category 1 and 2 applications. Dossiers for Category 3 applications must be provided in paper form, but the provision of an electronic copy is currently optional. For all applications, dossiers are required to comply with the Common Technical Document (CTD) organisational format. Details of the prescription medicines registration process requirements are located on the ARGPM page.
The Government's Digital Transition Policy requires all Australian Government agencies, including the TGA, to transition to a digital information and records management environment and limit the creation of paper records. By 2015, any records that are born digital will be accepted for transfer to the National Archives of Australia only in digital form.
New requirement for electronic copy of Category 3 application dossiers and safety-related requests with data
In order to comply with the Government's Digital Transition Policy and for the purpose of more efficient record management practices, the TGA is moving towards a fully electronic environment for application dossiers and associated documents.
As part of this transition, the TGA requests that sponsors of Category 3 applications and safety-related requests with data provide data to TGA in electronic form (CD or DVD) in addition to the currently required paper form. The provision of electronic data, in addition to hard copy data, is consistent with current requirements for Category 1 and Category 2 application dossiers.
The requirement for an electronic copy of Category 3 application dossiers will become effective from 1 January 2014; however, sponsors are asked to comply with this request wherever possible before that time.
How to provide the electronic copy of the data
In addition to the paper copy provided currently, sponsors are requested to provide a copy of the dossier on a readable, non-rewritable CD or DVD. Only one copy of the electronic version is required. Any subsequent documents provided to the TGA as part of the same application are also to be provided in hard copy (as per current practice) and electronic copy (either on a CD/DVD or as part of an attachment to an e-mail to the TGA). Labelling used to identify the electronic version must be the same as the labelling used to identify the paper document/s.
Electronic data formatting requirements
The CTD format is currently mandatory for the paper copy of Category 3 application dossiers. However, the TGA recognises that some sponsors may require more time to comply with CTD format and other TGA requirements for the electronic prescription medicine submission dossiers.
Therefore, until further notice, the TGA will accept any format for electronic dossiers for Category 3 applications provided the documents on the disc are created using commonly used software (e.g. adobe PDF, MS word and excel files), are readable, and the electronic file naming convention is identical to the paper file naming convention.
Sponsors are also requested to include in their application or cover letter a statement that all documents contained in the paper copy of the dossier are also contained on the electronic copy.