* Section 19 (1)(a) allows supply for Category A and Category B patients but, in practice, category A are dealt with under s18 and reg12A. Reg = Therapeutic Goods Regulations 1990 Figure 2 Access to unapproved medical devices Use in Clinical Trial Personal Importation Section 41HA MDReg 7.1 & Schedule 4 item 1.1 Special Access Scheme Authorised Prescriber Section 41HC Section 41JF MDReg 7.6, 7.7 CTN Section 41HA Subsec 41JD(1) MDReg 7.1 & Schedule 4, item 2.3 CTX Section 41HB Section 41JE MDRegs Category A Section 41HA Section 41JD MDReg 7.2 MDReg 8.2 Category B Section 41HB Subsec 41JE (1) TGA officers Authorised by external delegate Subsec 57(3) MDReg 10.6 MDReg = Therapeutic Goods (Medical Devices) Regulations 2002 Promotion of Unapproved Therapeutic Goods The promotion of unapproved therapeutic goods is an offence under subsection 22(6) of Chapter 3 (medicines) and Section 41MM of Chapter 4 (medical devices) of the Therapeutic Goods Act 1989 and carries a financial penalty. A person must not intentionally or recklessly make a claim, by any means, that the person or another person can arrange the supply of unapproved therapeutic goods. Clinical trials - an Overview A clinical trial is an experiment conducted in humans in order to assess the effects, efficacy and/or safety of a medicine, medical device, or procedure/intervention. Clinical trials of medicines and medical devices are undertaken to answer questions about their efficacy and safety. It is therefore necessary that the trial be conducted using appropriate experimental designs to obtain valid data without exposing people to unnecessary risks. The primary responsibility for monitoring a clinical trial rests with the sponsor, the institution in which the trial is being conducted and its HREC, and the investigator. Clinical trials should not be used by medical practitioners primarily as a means for obtaining an unapproved product for a particular patient. Information on other mechanisms for access to unapproved therapeutic goods is contained the TGA publication Access to Unapproved Therapeutic Goods in Australia and the separate TGA publications relating to each mechanism of supply. Practitioners should consult these documents for guidance if they are unsure which is the appropriate mechanism to pursue. 7.5
Delegate An officer who has been authority by the Minister or Secretary to exercise a power, which the Act or Regulations confer on the Minister/Secretary. Ethics Committee see ‘Human Research Ethics Committee’, below Exempt Goods Relates to the provisions of Chapters 3 or 4 of the Act, and covers that are exempted from the requirement to be included in the Register of Therapeutic Goods or are exempted from licensing requirements. Formulation A list of the ingredients used in the manufacture of a dosage form and a statement of the quantity of each ingredient in a defined weight, volume, unit or batch. Gene and Related Therapies Research Advisory Panel (GTRAP) A subcommittee of the Research Committee, established in 1994 to provide HRECs with advice about medical, scientific, ethical and safety issues related to gene therapy protocols. It provides advice to researchers to facilitate design of protocols for gene therapy and maintains a register of human gene therapy trials undertaken in Australia. Membership of GTRAP includes gene therapy, xenotransplantation and human stem cell research experts, members of the Gene Therapy Technical Advisory Committee (GTTAC), a representative from the TGA, an ethicist and a lawyer. Gene Therapy and Related Therapies As originally conceived, gene therapy is the introduction of DNA (deoxyribonucleic acid) or RNA (ribonucleic acid) into the cells of humans using a gene carrier or 'vector' to carry a gene into cells with a view to integration of the gene into chromosomal DNA and its long term expression. The NHMRC considers introduction of DNA or RNA into somatic (nonreproductive) cells to be ethically acceptable. However, it considers the introduction of DNA or RNA into germ (reproductive) cells to be ethically unacceptable since there is insufficient knowledge about the possible consequences including hazards and effects on future generations. HRECs would not be expected to receive, and should not approve, research proposals for germ cell gene therapy. Recent novel and varied methodologies for introducing and modifying gene expression overlap with the traditional concept of gene therapy. These include modifications to immunisation strategies, in which DNA, rather than protein is used to generate an immune