Autologous human cells and tissues (HCT) products – information about the potential impact to your operations
(This may be of interest to members)
We have received the communication below from firstname.lastname@example.org advising of the changes to the regulation of autologous human cells and tissue.
Please see the guidelines – Regulation of platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum
This is to remind you that changes to the regulation of autologous human cells and tissue (HCT) products, such as adipose-derived stem cells, will be fully effective from 1 July 2019. This follows a one year transition period to allow you to implement any necessary changes to comply with the new regulatory requirements. If you do not comply with the new requirements then you must cease supply of your product from 1 July 2019. In the ‘Updates’ section below, please also note the clarifications to the exclusion criteria for autologous HCT and classification of conditioned serum.
What are the new requirements that apply to my autologous HCT
- The product is included in the Australian Register of Therapeutic Goods (ARTG); or
- Approval has been granted or the TGA has been notified utilising the ‘unapproved’ product pathways (e.g. clinical trials, Special Access schemes), where specific criteria are met; or
- An application has been made for GMP certification, a clinical trial exemption (CTX) or inclusion in the ARTG (where further transition arrangements may apply); and
- The manufacturing facility satisfies good manufacturing practice (GMP) requirements and is TGA licensed.
All autologous HCT products must also comply with advertising prohibitions/requirements.
For clarity, supply of products that are cell fractions isolated from adipose tissue are likely to be subjected to full regulation from 1 July 2019. The process to dissociate the cell-cell contacts and isolate the cellular portion from the adipose tissue is considered to constitute more than minimal manipulation.
What levels of regulation apply to autologous HCT?
Detailed guidance is available on our website, of the different levels of regulation that may apply to your autologous HCT, including interpretation of the provisions.
To determine how your autologous HCT will be regulated by the TGA check whether it is:
- excluded from TGA regulation
- regulated by TGA with exemptions from some requirements
- fully regulated by TGA (as a medicine or biological)
How can I get product-specific advice from the TGA?
If you would like further advice from us, the following options are available:
- Download and complete a Request for advice – Biologicals form, and send to email@example.com
- Request a pre-submission meeting
- Meet us at your local SME Assist workshop. You can subscribe to the SME Assist email list to stay up to date with the latest SME information from TGA.
If you have questions or feedback please contact us at firstname.lastname@example.org
- We have clarified that conditioned serum meets the definition of minimal manipulation and thus will be regulated as a blood component, equivalent to platelet-rich plasma (PRP). Amended guidance on the regulation applicable to platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and conditioned serum is attached for your reference. This will be published soon on our website.
- A minor amendment was made to clarify that the hospital exclusion criterion for autologous HCT products allows storage and testing to occur under contract with the hospital. For further information refer our website.
- Further guidance will soon be available on how to ensure your publications on HCT products will comply with the prohibitions on advertising them. This will be published on Advertising Hub soon.
What happens if I continue to advertise or supply my autologous HCT?
There are a range of regulatory tools available to us to address non-compliance with the therapeutic goods regulatory framework. Non-compliance exposes you to risk of enforcement, the tools of which are also set out in the Regulatory Compliance Framework and Complaints handling for the Advertising of therapeutic goods to the Australian public.”
The International collaboration of transfusion medicine guidelines (ICTMG)
The ICTMG or International Collaboration for Transfusion Medicine Guidelines, was established in 2011 and includes international transfusion experts. The goal of the ICTMG is to create and promote evidence-based clinical guidelines to optimize transfusion medicine.
Several ANZSBT members are also members of ICTMG and have been co-authors of the guidelines. ANZSBT members may find visiting the ICTMG website helpful and of interest:
Patient Blood Management Guidelines
The Patient Blood Management Guidelines are a suite of six evidence-based, NHMRC-approved modules focusing on patient blood management. A Clinical/Consumer Reference Group was established for each module, comprising representatives from relevant clinical colleges and societies, including ANZSBT. The guidelines are available on the National Blood Authority’s website.
- Critical Bleeding/Massive Transfusion
- Critical Care
- Obstetrics and Maternity
- Neonatal and Paediatrics
National Safety and Quality Health Service Standards (second edition), November 2017
Australian Commission on Safety and Quality in Health Care
Guidelines for the management of haemophilia in Australia, July 2016
Australian Haemophilia Centre Directors’ Organisation in collaboration with the National Blood Authority.
An update of consensus guidelines for warfarin reversal, March 2013
Australasian Society of Thrombosis and Haemostasis
Medical refrigeration equipment – For the storage of blood and blood products – Manufacturing requirements
AS 3864.1-2012 , November 2012
Medical refrigeration equipment – For the storage of blood and blood products – User-related requirements for care, maintenance, performance verification and calibration AS 3864.2-2012, November 2012
Guidelines for Management of Factor VII Deficiency, May 2010
Australian Haemophilia Centre Directors’ Organisation
Evidence-based clinical practice guidelines for the use of recombinant and plasma-derived FVIII and FIX products, June 2006
Australian Health Ministers’ Advisory Council