{"id":"F2017L01288","name":"Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017","slug":"therapeutic-goods-order-no-94-standard-for-haematopoietic-progenitor-cells-derived-from-cord-blood-2","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97220,"registerId":"commonwealth-F2017L01288-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017","content":"![](image.001.png)\n\nTherapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017\n\nTherapeutic Goods Act 1989\n\nI, LARRY KELLY, a delegate of the Minister for Health for the purposes of subsection 10(1) of the Therapeutic Goods Act 1989, make the following order.\n\nDated 26 September 2017\n\n(Signed by)\n\nLARRY KELLY\n\nDelegate of the Minister for Health\n\n1 Name of order\n\nThis order is the Therapeutic Goods Order No. 94 (Standard for Haematopoietic Progenitor Cells derived from Cord Blood) 2017.\n\n2 Commencement\n\n(1) Each provision of this order specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n```html\n

Commencement information

Column 1

Column 2

Column 3

Provisions

Commencement

Date/Details

1. The whole of this order

30 September 2017

\n```\n\nNote: This table relates only to the provisions of this order as originally made. It will not be amended to deal with any later amendments of this order.\n\n(2) Any information in column 3 of the table is not part of this order. Information may be inserted in this column, or information in it may be edited, in any published version of this order.\n\n3 Authority\n\nThis order is made under subsection 10(1) of the Therapeutic Goods Act 1989.\n\n4 Interpretation\n\nIn this order:\n\nAct means the Therapeutic Goods Act 1989.\n\ncord blood means the blood remaining in the human placenta and umbilical cord after the umbilical cord has been clamped.\n\nNetCord-FACT International Standards means the document titled NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration, Sixth Edition, published by NetCord and the Foundation for the Accreditation of Cellular Therapy in July 2016, as in force at that time.\n\nhaematopoietic progenitor cells means self-renewing or multi-potent stem cells, or both, capable of maturation into haematopoietic lineages, lineage-restricted pluri-potent progenitor cells, or committed progenitor cells.\n\nNote 1 A number of expressions used in this order are defined in the Act, including the following:\n\n(a) manufacture;\n\n(b) Register;\n\n(c) standard; and\n\n(d) therapeutic goods.\n\nNote 2 NetCord-FACT International Standards are available for free download from the Foundation for the Accreditation of Cellular Therapy website: www.factweb.org/forms/store/ProductFormPublic/sixth-edition-netcord-fact-international-standards-for-cord-blood-collection-banking-and-release-for-administration-free-download.\n\n5 Repeal\n\nThis order repeals the instrument specified in Schedule 1.\n\n6 Application\n\n(1) Subject to subsection (2), this order applies to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.\n\n(2) This order does not apply to therapeutic goods that are haematopoietic progenitor cells derived from:\n\n(a) bone marrow;\n\n(b) peripheral blood;\n\n(c) cord blood that is processed beyond minimal manipulation; and\n\n(d) any tissue other than cord blood.\n\n7 Standard\n\n(1) The matters specified in this order constitute a standard for the purposes of subsection 10(1) of the Act in relation to therapeutic goods that are haematopoietic progenitor cells derived from cord blood.\n\n(2) For the purposes of this order, the requirements provided in the NetCord-FACT International Standards are specified as minimum requirements for the manufacture of therapeutic goods that are haematopoietic progenitor cells derived from cord blood.\n\n8 Transitional arrangements\n\n(1) In this section –\n\nformer standard means the instrument specified in Schedule 1, as in force immediately before the commencement of this order.\n\ntransition period means the period beginning on the commencement of this order and ending on 30 September 2018.\n\n(2) Despite the repeal of the former standard made by section 5 of this order, that standard continues to apply for the duration of the transition period in relation to the manufacture of therapeutic goods that are haematopoietic progenitor cells derived from cord blood, if the cells comprising those goods were collected before or during the transition period.\n\nSchedule 1 Repeal\n\n(section 5)\n\n```html\n

Repeal of instrument

Item

Instrument name and date of making

Register ID

1

Therapeutic Goods Order No. 75 – Standard for Haematopoietic Progenitor Cells Derived from Cord Blood (1 August 2007)

F2007L03598

\n```\n\nNote\n\n> Note: 1. All legislative instruments and compilations are registered on the Federal Register of Legislation under the Legislation Act 2003. See http://www.legislation.gov.au","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation maintains its original, narrow scope. It updates the technical standard for cord blood-derived haematopoietic progenitor cells from the 2007 version to the 2016 NetCord-FACT standards, without expanding to cover other cell types or sources. The exclusions in section 6(2) reinforce the original intent to focus specifically on minimally manipulated cord blood products."},"complexity_factors":["Short instrument: only 8 substantive sections plus a schedule","Minimal defined terms: only 4 explicit definitions in section 4 (Act, cord blood, NetCord-FACT International Standards, haematopoietic progenitor cells), plus 4 terms referenced from the parent Act via notes","Single external incorporation by reference: the NetCord-FACT International Standards (Sixth Edition) — though this delegates substantial technical content to an external 100+ page document, the legislative mechanism itself is straightforward","Simple conditional logic: one exclusion clause in section 6(2) with four straightforward exceptions","No nested exceptions or complex cross-referencing within the instrument itself","Clear structure: application, standard-setting, transitional arrangements, and repeal are logically separated"],"plain_english_summary":"This order imposes minimum safety and quality standards for haematopoietic progenitor cells derived from cord blood—requiring cord blood banks, manufacturers and clinicians to follow the NetCord‑FACT International Standards (6th Ed., July 2016). It excludes bone marrow, peripheral blood, heavily processed cord blood, and non‑cord tissues.\n\nBy aligning collection, processing, storage and release practices with an international benchmark, it protects patients receiving cord blood transplants; a 12‑month transition allowed phased compliance."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This order does not substantially change the scope of regulation compared with the previous instrument; it continues to regulate haematopoietic progenitor cells derived from cord blood and maintains the same product-type exclusions (see section 6). The principal change is technical: the order replaces the older standard (TGO 75) with a new minimum manufacturing standard by specifying the NetCord-FACT Sixth Edition (2016) (sections 5, 7 and Schedule 1) and provides a limited transition period for existing collections (section 8)."},"complexity_factors":["Short instrument (few sections: name, commencement, authority, interpretation, repeal, application, standard, transitional arrangements, Schedule 1)","Single external technical reference (NetCord-FACT Sixth Edition, July 2016) specified as the minimum requirement (section 7(2) and section 4 definition)","Limited number of defined terms within the instrument (Act, cord blood, NetCord-FACT International Standards, haematopoietic progenitor cells) (section 4)","Clear scope exclusions (bone marrow, peripheral blood, cord blood processed beyond minimal manipulation, other tissues) (section 6(2))","A simple transitional arrangement with defined cut-off date (section 8)","Repeal of one prior instrument listed in Schedule 1 (concise cross-reference)"],"plain_english_summary":"**What this instrument does (mechanically)\n\n- Names and brings into force a Therapeutic Goods Order (TGO 94) that sets a manufacturing standard for haematopoietic progenitor cells (HPCs) derived from cord blood (see sections 1, 2, 7).\n- Specifies that the technical minimum requirements for manufacture are the NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration (Sixth Edition, July 2016) (section 4 definition and section 7(2)).\n- Repeals the prior instrument (TGO 75) and places that repeal in Schedule 1 (section 5 and Schedule 1).\n- Provides a limited transitional arrangement allowing the old standard to continue to apply to cells collected before or during the transition period (from commencement until 30 September 2018) even though the old instrument is repealed (section 8).\n- Limits the scope: the order applies only to HPCs derived from cord blood and does not apply to HPCs from bone marrow, peripheral blood, cord blood processed beyond minimal manipulation, or any tissue other than cord blood (section 6).\n\nWho is affected and who pays\n\n- Primary affected parties: cord blood banks, blood-collection services, clinical laboratories and any manufacturer or sponsor that collects, processes, banks or releases cord-blood-derived haematopoietic progenitor cells for use as therapeutic goods (see sections 6 and 7).\n- Financial and operational costs fall on those entities: they must comply with the NetCord-FACT minimum requirements for manufacture (documentation, facilities, procedures, staff training, record-keeping and likely accreditation or audits) to supply products that qualify as therapeutic goods under the Act (section 7(2)).\n\nWho decides and how it binds them\n\n- The order is made under the Therapeutic Goods Act 1989 by a delegate of the Minister (section 3). It operates by specifying a standard (subsection 10(1) of the Act is the head of power cited in section 3).\n- The order itself does not create new licensing mechanisms; it prescribes the minimum manufacture standard that regulators will expect for cord-blood-derived HPCs that are regulated as therapeutic goods (section 7(1) and 7(2)).\n\nWhy it matters (stated purpose and mechanical effect)\n\n- The stated purpose is to set a recognised, external technical standard (NetCord-FACT 2016) as the minimum manufacturing requirements for cord-blood HPCs so that regulated products meet accepted collection, banking and release practices (section 7(2)). Mechanically, failure to meet those minimums will mean manufacturing does not meet the standard the Act requires for those therapeutic goods.\n\nImplementation, incentives and trade-offs\n\n- Firms face compliance costs: adopting the external standard will typically require procedural changes, record-keeping, staff training, possible facility upgrades and participation in periodic audits or accreditation processes referenced by NetCord-FACT (section 7(2)). Those are upfront and ongoing costs paid by the manufacturers/banks.\n- The order reduces regulatory uncertainty by fixing an identifiable external technical standard (the 2016 NetCord-FACT edition is named in section 4), rather than leaving unspecified requirements to administrative discretion. That reduces ambiguity but transfers reliance to an external technical document.\n- The instrument fixes the reference to a specific edition (the Sixth Edition, July 2016) “as in force at that time” (definition in section 4). That means the legal requirements are the contents of that edition at the time named; subsequent NetCord-FACT changes are not automatically incorporated unless the order is updated. This reduces drift but may require later regulatory updates if practice or technology changes.\n\nCompliance burden, discretion and implementation risk\n\n- Compliance burden: operators must align processes to the NetCord-FACT requirements (section 7(2)). This creates measurable compliance costs and administrative burden for smaller banks or new entrants, which could affect market entry and operating margins.\n- Bureaucratic discretion: the order itself delegates no additional discretionary powers, but it relies on the Therapeutic Goods Act and the regulator's enforcement and registration processes to verify compliance. The regulator will be the body that assesses whether manufacture meets the standard when considering regulatory actions under the Act.\n- Implementation risk: because the order binds to an external document, any ambiguity in how NetCord-FACT is interpreted in a regulatory context could lead to disputes; and because the order excludes cord blood processed beyond minimal manipulation (section 6(2)(c)), firms making more-than-minimally-manipulated products will be treated differently and may need alternative regulatory pathways.\n\nTransition and legacy stock\n\n- The order repeals TGO 75 (Schedule 1) but allows cord blood collected before or during the transition period to continue to be manufactured under the former standard until 30 September 2018 (section 8). That reduces immediate disruption for products already in collection or banking pipelines.\n\nImmediate legal effect vs policy rationale\n\n- Mechanically: manufacturers of cord-blood-derived HPCs must meet the NetCord-FACT (2016) minimum requirements to satisfy the standard the Act prescribes for those therapeutic goods (section 7(2)).\n- The explanatory rationale (external to the text) is that adopting NetCord-FACT aligns Australia’s minimum manufacturing requirements with internationally recognised technical standards; the order treats that as the justification for specifying the external document as the minimum requirement (see section 7(2)).\n\nKey sections to consult if you need to act\n\n- Scope and exclusions: section 6. \n- Minimum manufacturing requirements: section 7(2). \n- Definition of the referenced NetCord-FACT document: section 4. \n- Transitional arrangements and applicability to existing collections: section 8.\n\nPractical steps for affected entities\n\n- Review the NetCord-FACT (Sixth Edition, July 2016) and map existing procedures and records to its requirements (section 7(2)). \n- Budget for any facility, training, auditing or documentation changes needed to achieve compliance. \n- If holding cord blood collected before or during the transition period, determine whether the former standard applies to specific batches (section 8).\n\nThis summary focuses on what the order does and how it works mechanically. It does not take a view on the desirability of the chosen standard; it identifies who bears costs, who controls compliance, and where implementation risks and trade-offs arise (sections cited above)."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-order-no-94-standard-for-haematopoietic-progenitor-cells-derived-from-cord-blood-2","history":"/api/acts/therapeutic-goods-order-no-94-standard-for-haematopoietic-progenitor-cells-derived-from-cord-blood-2/history","analysis":"/api/acts/therapeutic-goods-order-no-94-standard-for-haematopoietic-progenitor-cells-derived-from-cord-blood-2/analysis","conflicts":"/api/acts/therapeutic-goods-order-no-94-standard-for-haematopoietic-progenitor-cells-derived-from-cord-blood-2/conflicts","importantCases":"/api/acts/therapeutic-goods-order-no-94-standard-for-haematopoietic-progenitor-cells-derived-from-cord-blood-2/important-cases","documents":"/api/acts/therapeutic-goods-order-no-94-standard-for-haematopoietic-progenitor-cells-derived-from-cord-blood-2/documents"}}