Consultation: Draft standards for faecal microbiota transplant (FMT) products

TGA sought comments from interested parties on proposed standards for faecal microbiota transplant (FMT) products in Australia. This is a new area of regulation for TGA from 2020.

Timetable

Document released for consultation on Friday, 15 November 2019.

Interested parties should respond by close of business Friday, 31 January 2020.

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

About the consultation

TGA is seeking comments from interested parties on proposed standards for FMT products in Australia.

Detailed guidance and justification is provided in the consultation paper on a new draft Therapeutic Goods Order (TGO): Standards for FMT Products.

Input is sought on specific questions raised within the consultation paper, as well as specific feedback on the applicable standards.

Note that the versions of the TGO and associated guidance provided in this consultation are not the final versions, and may be subject to change following feedback from this consultation.

For more detail, please refer to the consultation paper.

Background

FMT is the process of transplanting gut microflora either in human stool or products processed from human stool, from a healthy human donor into the bowel of a recipient with a medical condition.

Given the uncertainty among medical practitioners, hospitals and industry regarding the regulatory status of FMT products in Australia, a clear regulatory position was needed. In October 2018, TGA hosted a FMT stakeholder forum in Melbourne, and in January to March 2019 performed a public consultation on options for the regulation of FMT products.

After considering the stakeholder responses and conducting individual discussions with FMT providers, the Minister for Health determined a model by which the collection, manufacture and supply of FMT products are to be regulated in Australia from 2020. Details of the new regulatory model for FMT products are published on our website. It is anticipated that the new regulatory amendments for FMT products will be implemented on 1 January 2020 with a transition period of 12 months, i.e. commencement from 1 January 2021.

Under the new regulatory model, most FMT products will be classified as either:

• Class 1 biologicals, in the case of minimally manipulated FMT products from appropriately screened donors which are manufactured in a hospital and used in that hospital under the supervision of a registered medical practitioner who has clinical care of the recipient patient.
• Class 2 biologicals, in the case of minimally manipulated FMT products from appropriately screened donors which are manufactured in a facility that is not a hospital or manufactured in one hospital and used in another different hospitals or clinics.

Relevant to this consultation paper, standards applicable to donor selection and testing, storage and traceability needs to be developed and implemented. The current traceability requirements under Therapeutic Goods Order No. 87: General requirements for the labelling of biologicals (TGO 87) will apply for these FMT products. However, the current TGO to determine donor suitability and testing of biologicals - Therapeutic Goods Order No. 88: Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products (TGO 88) - does not provide sufficient controls for the screening of stool donors, given that human FMT products are sufficiently different in nature from other therapeutic goods of human origin (blood, cells and tissues). As a result, a separate, stand-alone TGO for FMT products is merited, and will outline the minimum quality and safety requirements with which biologicals derived from human stool must comply.

Content of submissions

TGA invites comments from interested parties. Comments can address any or all of the issues discussed in the consultation paper.

Enquiries

Any questions relating to submissions should be directed to Dr Tony Manderson, Principal Adviser, Biological Science Section, Office of Scientific Evaluation by email to: bloodandtissues@health.gov.au

Alternatively, by telephone to 1800 678 799 (free call within Australia).

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Privacy information

• The TGA collects your personal information in this submission in order to:
  • contact you if we would like to seek clarification of any issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available; and
  • 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.
• TGA will publish your name and (if applicable) your designation/work title on our website (i.e. make this information publicly available) if you consent to the publication of your name on the TGA website (please complete the cover sheet).
• Any text within the body of your submission that you want to remain confidential should be clearly marked 'IN CONFIDENCE'.
• 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.