* 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 Access to unapproved medical devices Figure 2 Use in Clinical Trial Personal Importation Special Access Scheme Authorised Prescriber Section 41HA Section 41HC MDReg 7.1 & Section 41JF Schedule 4 item 1.1 MDReg 7.6, 7.7 CTN CTX Category A Category B Section 41HA Section 41HB Section 41HA Section 41HB Subsec 41JD(1) Section 41JE Section 41JD Subsec 41JE (1) MDReg 7.1 & MDRegs MDReg 7.2 Schedule 4, 7.5 MDReg 8.2 item 2.3 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 and carries a financial penalty. A person must not intentionally or recklessly Goods Act 1989 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 and the separate TGA publications relating to each mechanism of supply. Australia Practitioners should consult these documents for guidance if they are unsure which is the appropriate mechanism to pursue.
* 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
clinical-trials-guidelines.docx