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Therapeutic Goods Order No. 73 - Standards for Haematopoietic Progenitor Cells Derived from Cord Blood

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      THERAPEUTIC GOODS ACT 1989
    THERAPEUTIC GOODS ORDER NO. 73
    STANDARDS FOR HAEMATOPOIETIC PROGENITOR CELLS DERIVED FROM CORD BLOOD     I, TERRY SLATER, delegate of the Minister for Health and Ageing for the purposes of section 10 of the Therapeutic Goods Act 1989 and acting under that section, having consulted with the Therapeutic Goods Committee in accordance with subsection 10(4) of that Act, HEREBY:   (1) DETERMINE that the matters specified in this Order constitute standards for haematopoietic progenitor cells derived from cord blood:   In this order:   Definitions   “haematopoietic progenitor cells” means primitive pluripotent haematopoietic cells   capable of self-renewal as well as maturation into any of the haematopoietic lineages,   including committed and lineage-restricted progenitor cells;   "cord blood" means blood  collected from human placental and umbilical cord blood vessels;   “quarantine” means the status of products which are awaiting a decision on their suitability for use.   Standards and requirements:   Haematopoietic progenitor cells derived from cord blood   Haematopoietic progenitor cells derived from cord blood must meet the requirements of the document entitled "International Standards for Cord Blood Collection, Processing, Testing, Banking, Selection and Release" Second edition, dated July 2001, published by the Foundation for the Accreditation of Cellular Therapy and Netcord
  2.      Haematopoietic progenitor cells derived from cord blood:   (i)                  must be manufactured only if a blood sample from the birth mother taken at the time of or up to 7 days after the collection of cord blood tests negative for HIV-1 and HCV using Nucleic Acid Amplification Technology; or   (ii)                must be quarantined, and may only be released from quarantine if a blood sample taken from the birth mother at least 180 days after the donation of cord blood tests negative for antibodies against HIV-1/2 and negative for antibodies against HCV.     This Order commences from the day after it is registered on the Federal Register of Legislative Instruments.      Dated this Eighth day of June 2005           Terry Slater Delegate of the Minister for Health and Ageing