EXPLANATORY STATEMENT
Subject: THERAPEUTIC GOODS ORDER NO. 73 – STANDARDS FOR HAEMATOPOIETIC PROGENITOR CELLS DERIVED FROM CORD BLOOD
Section 10, Therapeutic Goods Act 1989
OUTLINE
Therapeutic Goods Order No. 73 Standards for Haematopoietic Progenitor Cells Derived from Cord Blood (TGO 73) 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 73 introduces a key reference document that prescribes the minimum standard to be met by haematopoietic progenitor cells (HPCs) derived from cord blood. TGO 73 also reiterates the blood testing requirement that HPCs derived from cord blood only be manufactured if a birth mother tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology or must be quarantined and only released if a blood sample taken from the birth mother at least 180 days after the donation of the cord blood test negative for antibodies against HIV-1/2 and negative for antibodies against HCV.
TGO 73 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 the 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 (the Regulations) 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.
Up until April 2004 the standards for HPCs were described in Therapeutic Goods Order No 66 and No 66a Standards for Blood Components. These standards required that all blood and blood components including HPCs must meet the requirements of the Council of Europe (CoE) document ‘Guide to the preparation, use and quality assurance of blood components’ 8th edition (the Guide). These standards also required that blood and blood components only be manufactured from blood that tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology.
In April 2004 the new edition of the CoE document ‘Guide to the preparation, use and quality assurance of blood components’ (the 9th edition) was adopted by the TGA in Therapeutic Goods Order 72 (TGO 72). However, the new edition no longer contains requirements relating to HPCs. As a consequence of the removal of HPCs from the adopted 9th edition of the CoE Guide there is a need to adopt new standards for HPCs.
An expert advisory group, comprising members from the HPC sector, considered a number of domestic and international standards for adoption in Australia. The expert advisory group and subsequently the TGC agreed that the standards that should apply to HPCs derived from cord blood are the Netcord and the Foundation for the Accreditation of Cell Therapy (FACT) document International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release (2nd edition, July 2001). This document can be obtained from the FACT website.
TGO 73 prescribes this standard in order to fill the gap left by the removal of relevant standards for HPCs from the Guide. No other changes to the regulation of HPCs are proposed. That is, all of the other existing exemptions, the requirements for HPC manufacturers to hold a licence, the requirements for compliance with Good Manufacturing Practice and the requirements to submit a Technical Master File will be retained. The blood testing requirement in TGO 66 is retained in altered form in TGO 73.
CONSULATION
The proposed new standard has been discussed with the Australian HPC sector and they have indicated that the Netcord/FACT standard is the standard they prefer to be applied by the TGA. The TGC has endorsed the Netcord/FACT standard.
REGULATION IMPACT STATEMENT
The Office of Regulation Review has agreed that no Regulation Impact Statement is necessary (ORR ID number 6615) for TGO 73 as:
- the new standards are substantially the same as the previous standards that applied to HPCs derived from cord blood and have been in place since 2000;
- the proposed new standards have been discussed with the Australian HPC sector and they have indicated that the Netcord/FACT standards are the standards they prefer to be applied by the TGA;
- the proposed new standards are not likely to have any significant additional direct or indirect impact on the HPC sector; and
- the proposed new standards will ensure that Australia’s regulation of HPCs derived from cord blood remains internationally consistent.