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Consultation: Transition to eCTD only for prescription medicines

23 October 2018

This consultation closed on 4 December 2018.

The TGA is sought comments from interested parties and the views of stakeholders on our proposed transition plan for accepted eCTD only dossiers for prescription medicines.

Consultation documents

How to access a pdf or Word document

Timetable

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.

Background

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.

Enquiries

Any questions relating to submissions should be directed by email to 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.

Privacy information

  • 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.