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Consultation: Whether the TGA should publish that a prescription medicine is under evaluation

Submissions received

15 February 2019

This consultation closed on Friday, 29 March 2019.

The TGA sought comments from interested parties on whether or not the TGA should in future disclose earlier that a prescription medicine is under evaluation and what types of prescription medicines should be published.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Friday, 15 February 2019.

Interested parties should respond by close of business Friday, 29 March 2019.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

Are you a patient, consumer group, healthcare provider, industry representative body, company, researcher or other interested party?

We seek your views, including reasons in support or concerns, on four options for the point in time in the evaluation of an application for a registration of a prescription medicine that the TGA should publish the fact that evaluation is taking place and the types of prescription medicine applications that should be published.

Medicines that are considered in scope for this consultation are prescription medicines that are lodged as applications for:

  • New medicines (new chemical entities, new biological prescription medicines, new fixed dose combinations).
  • New uses for medicines (extension of indications).
  • Generic or biosimilar medicines.

Background

This paper reflects an increasing commitment to transparency by government agencies. There has been increased demand from the public for knowledge of a potential marketing approval for medicines. The TGA anticipates that this interest will continue to grow.

The TGA currently does not release information about the acceptance of an application for prescription medicine evaluation, nor about the ongoing evaluation of applications unless this information is already publicly available. Information about the status of an application for registration of a medicine is of commercial value to sponsors, in particular when a pharmaceutical patent exists. Pharmaceutical patents include patents for claims with active ingredients, new formulations and methods of production or use.

Content of submissions

Submissions may address any, or all, of the questions posed in the consultation paper.

We invite you to be clear in your submissions about the effect any increased transparency would have on you. Your input will alert us to implications of each option and will inform future steps. As an example, submissions might include the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits.

Enquiries

Any questions relating to submissions should be directed to the Transparency Reforms and Evaluation Support Section by email to tgaregreforms@health.gov.au or by telephone to the information line 1800 020 653.

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.

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.