EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NO. 75 – STANDARD FOR HAEMATOPOIETIC PROGENITOR CELLS DERIVED FROM CORD BLOOD
Section 10, Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods Order No. 75 Standards for Haematopoietic Progenitor Cells Derived from Cord Blood (TGO 75) is an Order made by the delegate of the Minister for Health and Ageing under section 10 of the Therapeutic Goods Act 1989 (the Act).
TGO 75 introduces a key reference document that prescribes the minimum standard to be met by haematopoietic progenitor cells (HPCs) derived from cord blood.
TGO 75 commenced on the day after it was registered on the Federal Register of Legislative Instruments.
BACKGROUND
The Act provides for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods for use in humans. The Therapeutic Goods Administration (TGA) is responsible for administering the Act.
Section 10 of the Act provides the Minister, or the Minister's delegate, with the power to determine standards for therapeutic goods, or to amend or revoke existing standards, after consultation with the Therapeutic Goods Committee (TGC), a committee established by the Therapeutic Goods Regulations 1990 to advise the Minister on standards.
Therapeutic goods must not be imported into Australia, or supplied in Australia, or exported from Australia unless they comply with any applicable standards determined under Section 10 of the Act.
Up until April 2004 the standards for HPCs were described in Therapeutic Goods Orders No 66 and No 66a Standards for Blood Components. In 2005, the TGC endorsed adoption of the document entitled International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release (2nd edition, July 2001) published by the Foundation for the Accreditation of Cell Therapy (FACT) and NetCord and a new Therapeutic Goods Order Number 73 mandating this standard was gazetted on 8th June 2005. Other requirements, compliance with the Manufacturing Principles and submission of a Technical Master File, were retained.
Recently, the FACT and NetCord published a revised edition entitled International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release (3rd edition, December 2006) (the Revised Edition) which contains no significant changes to requirements. Minor changes in the standard relate to consolidation of topic specific requirements, improved alignment of maternal blood sample testing with current regulatory requirements and facilitation of certain Australian Government policy goals.
TGO 75 revokes TGO 73 and adopts the Revised Edition. This document can be obtained from the FACT website. The requirement for manufacturers of HPCs derived from cord blood to hold a licence, the requirement for compliance with Good Manufacturing Practice and the requirement to submit a Technical Master File demonstrating compliance with the current TGO, will be retained.
CONSULATION
The proposed new standard has been discussed with the Australian HPC (cord blood) sector and they indicated that the standard contained in Revised Edition is the standard they prefer to be applied by the TGA. The TGC endorsed adoption of the Revised Edition.
REGULATION IMPACT STATEMENT
The Office of Best Practice Regulation agreed that no Regulation Impact Statement would be required for adoption of the Revised Edition through registration of TGO 75 as:
- the new standard is substantially the same as the previous standard that applied to HPCs derived from cord blood and have been in place since 2005;
- the proposed new standard was discussed with the Australian HPC sector and they indicated that the standard in the Revised Edition is the standard they prefer to be applied by the TGA;
- the proposed new standard is not likely to have any significant additional direct or indirect impact on the HPC sector; and
- the proposed new standard will ensure that Australia’s regulation of HPCs derived from cord blood remains internationally consistent.