Consultation: Options for the regulation of Faecal Microbiota Transplantation materials

Invitation to comment

The TGA sought comments from interested parties on Options for the Regulation of Faecal Microbiota Transplantation materials.

Timetable

Document released for consultation on Tuesday, 29 January 2019.

Interested parties should respond by close of business Friday, 15 March 2019.

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

About the consultation

This public consultation paper details the potential options for regulatory measures on the collection, manufacture and supply of FMT material, including the development of product specific requirements and standards.

Submissions received in response to this consultation will inform decisions by the Australian Government on future policies around the quality, safety and efficacy of FMT material for therapeutic use.

Background

Please refer to information available at: Faecal Microbiota Transplant (FMT)

Content of submissions

Submissions may address any, or all, of the questions or other identified issues.

In addition, submissions might include:

• Suggested improvements
• An assessment of how the proposed changes 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. This is important - the TGA is required to quantify the regulatory impact (burden and/or savings) of any proposed changes.

Enquiries

Any questions relating to submissions should be directed to the Biological Science Section by email to bloodandtissues@tga.gov.au or by telephone to 02 6232 8443.

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.