This consultation closes on 4 December 2018.
On this page: Invitation to comment | Consultation documents | Timetable | About the consultation | Background | Content of submissions | How to submit | Enquiries | What will happen | Privacy information | More information
Invitation to comment
The TGA is seeking comments from interested parties and the views of stakeholders on our proposed transition plan for accepted eCTD only dossiers for prescription medicines.
Documents released for consultation on Tuesday 23 October 2018.
Interested parties should respond by close of business Tuesday, 4 December 2018.
Feedback will be released following consideration of submissions. (see 'What will happen').
About the consultation
The TGA's electronic dossier reforms agenda is working towards providing an updated electronic submissions platform that is appropriate for Australian sponsors and is cognisant of the best-practice initiatives that are operating in the international environment. Providing a single, standardised dossier format forms part of this agenda.
The public consultation paper outlines our proposed model for transiting to accepting only eCTD formatted dossiers for prescription medicines.
Since 2011, the TGA has accepted medicine dossiers within an electronic format.
The eCTD format was introduced within Australia in 2015, however it has been internationally utilised since 2003, following sign off by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), with the purpose of standardising dossier format globally and making the process more efficient for sponsors and regulators.
Content of submissions
Submissions may address any, or all, of the amendments proposed within the Transition to eCTD only for prescription medicines consultation document or other identified issues.
In addition, submissions might include:
- Suggested improvements
- An assessment of how the proposed change will impact on you.
- What do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.
- Any suggestions for development of further education and guidance material.
How to submit
Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.
Alternatively, hardcopy submissions with a printed coversheet may be mailed to:
Business Systems Review and Reporting Section
Prescription Medicines Authorisation Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606
Any questions relating to submissions should be directed by email to firstname.lastname@example.org or by telephone to 02 6232 8887.
What will happen
All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).
Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.
Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.
- The TGA collects your personal information in this submission in order to:
- contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
- help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
- Seek feedback about how the consultation was undertaken.
- Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
- More information on consultations and privacy is included in the submission form and on our website.