Remaking of standards and legislative instruments for human cell and tissue products, blood and blood components

Closed 11 Jul 2021

Opened 27 May 2021

Overview

The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to remake some of the legislative instruments relating to human cell and tissue (HCT) products (including blood and blood components), which sunset in October 2021.

We are seeking feedback to make sure the proposed changes:

  • improve clarity on technical requirements
  • ensure alignment with international best practice and standards
  • bring legislation into alignment with recent amendments, including updates to autologous HCT requirements

Consultation documents

These documents contain the background of the change, the proposed remake and proposed guidance.

You will need to read these documents before submitting your response.

Consultation paper

TGO 107 - Biologicals labelling requirements

TGO 108 - HCT products donor selection requirements

TGO 109 - Standard for biologicals

Legislative instrument - Biologicals specified things

Why your views matter

The Orders are important to provide clarity, and to specify Australian-specific donor screening, labelling and manufacturing requirements for therapeutic goods comprising, derived from or containing human cell and tissue products, including blood and blood components to ensure their quality and safety for Australian patients and consumers.

We are seeking feedback from stakeholders on the suitability and potential impact of the remade TGOs (107, 108 and 109) and the merged legislative instrument.

Making a submission

1. Read the consultation documents about the proposed changes, and the reasoning on why we propose the change (links above). 

2. Go to the online consultation questions, complete and submit your response (link below)

What happens next

Submissions will be reviewed by the TGA and a summary of the submissions will be posted on this website. A decision about remaking the TGOs will be made after submissions have been considered.

Sponsors of existing HCT products will be required to submit a single notification for included biologicals to confirm their ongoing compliance after these TGOs are remade.

Audiences

  • Anyone from any background

Interests

  • Hospitals
  • e-Health
  • Health technology
  • Legislation
  • Health insurance
  • Rural health services
  • Regulatory policy
  • Women's health
  • Children's health
  • Chronic disease
  • Communicable diseases
  • Drugs and substance abuse
  • Organ and tissue donation
  • Immunisation
  • Aboriginal and Torres Strait Islander health
  • Environmental health
  • Prescription drugs
  • Preventative health
  • Dental health
  • Strategic Policy
  • Policy Development