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Consultation: Revision of TGO 75 Standard for haematopoietic progenitor cells derived from cord blood

26 May 2017

This consultation closed on 7 July 2017

The TGA sought comments from interested parties on the proposed options to revise TGO 75.

This consultation provided an opportunity for cord blood banks (CBBs) and other stakeholders to comment on the proposed options, including the development of the new Order.

Consultation documents

How to access a pdf or Word document

Consultation attachments

Timetable

Document released for consultation on Friday 26 May 2017.

Interested parties responded by close of business Friday 7 July 2017.

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

About the consultation

The Therapeutic Goods Order No. 75 Standard for Haematopoietic Progenitor Cells Derived from Cord Blood (TGO 75) establishes a standard for Haematopoietic Progenitor Cells (HPCs) derived from cord blood.

TGO75 specifies that HPCs derived from cord blood must meet the requirements of the 3rd edition of the Foundation for Accreditation of Cellular Therapy (FACT) and NetCord document titled International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection, and Release (NetCord-FACT International Standards 3rd Edition).

The FACT and NetCord publish updated editions of the international standards every three years. The 6th edition titled International Standards for Cord Blood Collection, Banking, and Release for Administration (NetCord-FACT International Standards 6th Edition) was published in July 2016 and is the current edition. This edition is available for free download from the FACT website.

TGO 75 has been in force since 1 August 2007. In accordance with the Legislation Act 2003, legislative instruments (such as TGO 75) are automatically repealed after a fixed period of time (subject to some exceptions). This automatic repeal is called sunsetting. TGO 75 is due to sunset on 1 October 2017. Accordingly, we are considering options for remaking an order under subsection 10(1) of the Act which specifies a standard for HPCs derived from cord blood. A new Order would ensure that HPCs derived from cord blood continue to be the subject of an applicable ministerial standard following the automatic repeal of TGO 75.

We are considering whether the new standard should specify the requirements of the 3rd or 6th edition of the NetCord-FACT International Standards 6th Edition for HPCs derived from cord blood. Specifying the requirement of the 6th Edition would align cord blood regulation in Australia with international best practice and maintain consumer confidence in the regulation of these products.

Submissions

Submissions may be provided on the proposed options stated in the consultation paper of TGO75 revision, and possible impact as a result of the proposed change on 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 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.