Consultation: Regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals

25 August 2016

This consultation closed on 27 October 2016.

Invitation to comment

The TGA sought comments from interested parties on revised options that address the issues raised by stakeholders on the current regulation of autologous cell and tissue products, including autologous stem cells.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Thursday 25 August 2016.

Interested parties should respond by close of business on Thursday 6 October 2016.

Late submissions may be accepted until 27 October 2016 by email to bloodandtissues@tga.gov.au. Please contact the Biological Sciences Section to request an extension.

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

About the consultation

In January 2015, the Therapeutic Goods Administration (TGA) published a Consultation Paper on the regulation of autologous stem cell therapies (Consultation: Regulation of autologous stem cell therapies - Discussion paper for consultation - January 2015). The TGA received 80 submissions to this consultation.

The TGA sought comments from interested parties on the revised options that address the issues raised by stakeholders in response to the January 2015 Consultation Paper. Submissions may address the consequences of the proposed revised options, including any implications for the broader biologicals framework.

Background

Human cells and tissues (HCTs) are used in many therapeutic applications. They 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 well defined. 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 collected
  • manufactured by, and used, on that patient under the supervision of a medical practitioner who is caring for that patient
  • used for a single indication in a single course of treatment for that patient.

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

In recent years, the number of companies and medical clinics offering services involving the use of 'autologous stem cells' that are not regulated under the Therapeutic Goods Act 1989 has increased. Concerns expressed to the TGA about these therapies include:

  • the safety of the products - either direct safety impacts or safety issues incidental to the therapy
  • the lack of evidence to support the efficacy of the product
  • the large sums of money being charged for unproven treatments
  • the lack of mechanisms for reporting of adverse effects of the products and
  • inappropriate advertising of the product to consumers.

Submissions

Submissions may address any, or all, of the questions raised in the consultation document (Regulation of autologous cell and tissue products and proposed consequential changes to the classification of biologicals or other identified issues).

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 1800 678 799.

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.