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.
Overview
The Therapeutic Goods Order No. 75, effective under Section 10 of the Therapeutic Goods Act 1989, addresses the need for a uniform and internationally consistent standard for haematopoietic progenitor cells (HPCs) derived from cord blood. Enacted by the delegate of the Minister for Health and Ageing, this Order serves to replace the previous standards outlined in Therapeutic Goods Orders No 66 and No 66a. The primary policy objective of TGO 75 is to ensure that HPCs meet stringent quality and safety standards, aligning with the International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release (3rd edition, December 2006) published by the Foundation for the Accreditation of Cell Therapy (FACT) and NetCord. This standard ensures that HPCs derived from cord blood are safe and effective for use in humans, thereby maintaining the quality and safety of therapeutic goods within Australia. The Order mandates that HPCs derived from cord blood must comply with the new standards to be legally supplied, imported, or exported within Australia.
Scope and Application
Therapeutic Goods Order No. 75, issued under section 10 of the Therapeutic Goods Act 1989, sets the minimum standard for haematopoietic progenitor cells derived from cord blood. This Order applies to entities and persons involved in the collection, processing, testing, banking, selection, and release of these cells within Australia. The scope of the Order is national, ensuring that all therapeutic goods related to haematopoietic progenitor cells derived from cord blood must comply with the standards prescribed within TGO 75 when being imported, supplied, or exported in Australia. The Order revokes the previous standard established by TGO 73 and adopts a revised edition of the international standards published by the Foundation for the Accreditation of Cell Therapy and NetCord. The application of these standards ensures that the quality, safety, and efficacy of therapeutic goods derived from cord blood align with international best practices and regulatory requirements. Entities must still comply with Good Manufacturing Practice and hold a valid licence, as well as submit a Technical Master File to demonstrate adherence to the current TGO.
Key Provisions
Therapeutic Goods Order No. 75 (TGO 75) sets the minimum standard for haematopoietic progenitor cells (HPCs) derived from cord blood, established under section 10 of the Therapeutic Goods Act 1989 (the Act). This Order revokes the previous TGO 73 and adopts the revised International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release (3rd edition, December 2006) published by the Foundation for the Accreditation of Cell Therapy (FACT) and NetCord. The primary focus of TGO 75 is to ensure that HPCs derived from cord blood meet specific quality and safety standards for use in humans. It is essential for these therapeutic goods to comply with TGO 75 to be imported, supplied, or exported within Australia.
Under TGO 75, manufacturers of HPCs derived from cord blood are required to adhere to Good Manufacturing Practice (GMP) and maintain compliance with the International Standards as outlined in the Revised Edition. They must also submit a Technical Master File that demonstrates adherence to the current TGO, showcasing their compliance with all relevant standards. These obligations are critical to ensuring the safety and efficacy of the therapeutic goods and are integral to the national system of controls established by the Act. Furthermore, manufacturers must hold a valid licence to operate, ensuring that they meet the regulatory requirements set forth by the Therapeutic Goods Administration (TGA).
Failure to comply with TGO 75 can result in significant consequences. Importing, supplying, or exporting HPCs derived from cord blood that do not meet the specified standards is prohibited under the Act. Entities found in breach of these provisions may face legal action, including fines and other penalties. The severity of these penalties is determined based on the nature and extent of the non-compliance, but they are designed to enforce adherence to the standards and protect public health. Ensuring compliance with TGO 75 is crucial for maintaining the integrity of the therapeutic goods market in Australia.