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Consultation: Regulation of autologous stem cell therapies

Related information

Discussion paper for consultation

6 January 2015

This consultation closed on 3 March 2015

The TGA sought comments from interested parties on Regulation of autologous stem cell therapies - Discussion paper for consultation.

Consultation documents

How to access a pdf or Word document

Timetable

Documents released for consultation on Tuesday 6 January 2015.

Interested parties responded by close of business Tuesday 3 March 2015.

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

About the consultation

The TGA is considering whether the regulation applied to some autologous cells is appropriate.

The specific autologous stem cells under consideration are those that are taken from a patient and used under the supervision of a medical practitioner who is caring for that patient for a single indication in a single course of treatment.

The purpose of this paper is to seek your input on this issue and, in particular, on five potential options for regulation of these cells as therapeutic goods under the Therapeutic Goods Act 1989 (the Act).

Response to the consultation will help inform what, if any, regulatory change is needed.

Feedback from the consultation will inform whether a change is required to therapeutic goods regulation and inform any Regulation Impact Statement (RIS). Any RIS will undergo further consultation, including consultations on costs / benefits to affected parties.

Background

Human cells and tissues are used in many therapeutic applications. Human cell and tissue products (HCTs) can be derived and used as part of medical practice or supplied as products manufactured for therapeutic use. The boundary between HCTs derived and used solely as part of medical practice and those supplied as products manufactured for therapeutic use (usually as part of medical practice) is not always clear. Medical practice and therapeutic products are overseen by different regulatory frameworks.

Autologous cells are those that are removed from, and applied to, the same person, so the donor and the recipient are the same. Some autologous HCTs are currently captured under Therapeutic Goods (Excluded Goods) Order No. 1 of 2011 (the Order), provided they are:

  • for use in the patient from which they were taken
  • used under the supervision of a medical practitioner who is caring for that patient
  • for a single indication in a single course of treatment.

This means that the Secretary (through a delegate) has declared them not to be therapeutic goods for the purpose of the Therapeutic Goods Act 1989 (the Act), therefore, they are not regulated by the TGA.

There are some autologous HCTs that may be captured under the Order for which there are currently no public health concerns.However, other autologous cells particularly 'autologous mesenchymal stem cells', are being used in an increasing number of therapeutic applications. It is these 'autologous mesenchymal stem cells' in particular which are the subject of the proposed public consultation.

Content of submissions

Submissions may address any part or all of the Regulation of autologous stem cell therapies - Discussion paper for consultation or other identified issues.

See: Submissions received

What will happen

All submissions will be placed on the TGA Internet site unless marked confidential or indicated otherwise in the submission cover sheet (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through the TGA Internet site.

Privacy infomation

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).

The TGA will disclose your name and (if applicable) your designation/work title on the TGA Internet site (i.e. make this information publicly available) if you consent to the publication of your name on the TGA Internet site (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.

Enquiries

Any questions relating to submissions should be directed to the Dr Tony Manderson, Principal Adviser, Biological Science Section, Office of Scientific Evaluation by email to bloodandtissues@tga.gov.au or by telephone to 1800 678 799.