Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018: Guideline

Purpose The purpose of this Guideline is to outline the circumstances in which items included in the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 (the legislative instrument), being certain products that comprise, contain or are derived from human cells or tissues, would not be within the TGA regulatory...

Purpose

The purpose of this Guideline is to outline the circumstances in which items included in the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 (the legislative instrument), being certain products that comprise, contain or are derived from human cells or tissues, would not be within the TGA regulatory framework.

Background

Subsection 7AA(2) of the Act provides that the Minister may, by legislative instrument, determine that specified goods (other than goods declared to be therapeutic goods under an order in force under section 7) when used, advertised or presented for supply in a way specified in the determination, are excluded goods for the purposes of this Act. The principal purpose of the Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018 (the Determination) is to reflect products excluded from the regulatory scheme.

It replaces Items (4(o), 4(p), 4(q) and 4(r)) of the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011.

Item 4(a): Exclusion of certain autologous human cell and tissue products

Detailed guidance is provided for this exclusion at ‘Biological regulatory framework changes from 1 July 2018’.

Item 4(b): Exclusion of solid organs for direct donor-to-host transplantation

The purpose of this Item (which was also included in the 2008 Excluded Goods Order) is to exclude organs for direct donor-to-host transplantation from the operation of the Act and Regulations. It should be noted that only the organs are excluded from the definition of therapeutic goods. The Act may still apply, for instance, to equipment and materials that are used for the manufacture of the product and may still therefore be subject to regulation by the TGA.

Item 4(c): Exclusion of haematopoietic progenitor cells for direct donor-to-host transplantation

The provisions for exclusion of 'bone marrow' in the 2008 Excluded Goods Order were updated in the Order to reflect current terminology and practice in the field of haematopoietic progenitor cells (HPC) transplantation by replacing 'bone marrow' with HPC.

The purpose of this Item is to exclude from the operation of the Act and Regulations (and thus regulation by the TGA) HPC products for direct donor-to-host transplantation for haematopoietic reconstitution. The updated 4(c) recognises that it is HPCs extracted from bone marrow that are transplanted.

It should be noted that only the HPC are excluded from the definition of therapeutic goods. Equipment and materials that are used for the manufacture of the product may still be therapeutic goods to which the Act and Regulations apply and thus are subject to regulation by the TGA.

Item 4(d): Exclusion of reproductive tissue

Item 4(d) of the Order excludes 'reproductive tissue for use in assisted reproductive therapy' from the operation of the Act and Regulations. This exclusion reflects the decision of the Australian Health Ministers Conference (AHMC) in July 2008 that reproductive tissues should not be regulated by the TGA because use of these tissues was already coherently and consistently managed.

It should be noted that only the reproductive tissue itself is excluded from the definition of therapeutic goods. Equipment and materials that are used for the manufacture of the product may still be therapeutic goods to which the Act and Regulations apply and thus are subject to regulation by the TGA.

The comments above on the professional responsibilities of treating medical practitioners are equally applicable in relation to these goods.

Version history

Version Description of change Author Effective date
V1.0 Original publication Office of Scientific Evaluation 03/12/2012
V1.1 Minor changes regarding professional responsibilities of treating practitioners Office of Scientific Evaluation 25/03/2013
V2.0

Exclusion requirements for reproductive tissue, haematopoietic progenitor cells for direct donor-to-host transplantation and solid organs for direct donor-to-host transplantation, from the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011, item 4 (o),(p) and (r), migrated to the new legislative instrument Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018. The guidance was updated to reflect this legislative change.

Guidance on the exclusion criteria for autologous human cells and tissue revised to clarify the new requirements in the new legislative instrument Therapeutic Goods (Human Cells, Tissues and Organs) Determination 2018.

Scientific Evaluation Branch 2 July 2018
Source: www.tga.gov.au