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Transition arrangements for autologous HCT products

Australian Regulatory Guidelines for Biologicals (ARGB)

27 July 2018

From 1 July 2018, transitional arrangements apply to autologous HCT products that are no longer excluded from regulation. The transition arrangements allow goods that will not be excluded under the new legislation to have certain exemptions until 30 June 2019.

The transition is intended to allow patients that have been scheduled for treatment to complete the procedure, and to allow suppliers time to move towards compliance with the new requirements.

At any time during the transition period you can begin to supply autologous HCT products that comply with the new requirements, where appropriate approval has been granted.

When transitional arrangements apply

The transitional arrangements apply only in the following specific circumstances:

Where an autologous HCT product has been supplied prior to 1 July 2018 (including in clinical trials) this can continue until 30 June 2019.

If you were not supplying the autologous HCT product prior to 1 July 2018 this provision does not apply.

Regulatory requirements which must be adhered during transition period

All autologous HCT products must comply with following requirements during and after the transition period:

Exemptions from certain requirements during the transition period

During the transition period applicable autologous HCT products can be supplied without meeting the following regulatory requirements:

Storage beyond transition period

Any autologous HCT products stored beyond the transition period, which do not comply with all the new requirements, including manufacturing in a GMP certified/licenced facility, can only be supplied using the 'unapproved' product pathways (e.g. clinical trials under CTN route, Special Access schemes), where appropriate. Alternatively, justification for supply of stored product could be considered and potentially approved as part of the review of any CTX or market authorisation application.

Further transition arrangements where an application has been submitted

Where an application is made for GMP certification, a CTX, or for inclusion in the ARTG, further transition provisions may be available in the following circumstances:

  • Application for GMP certification. Where an autologous HCT product is being supplied as part of an approved Human Research Ethics Committees (HREC) clinical trial prior to 1 July 2018, and the recruitment and supply of the product will not be completed by 30 June 2019.

    If you have notified the TGA of the trial under the Clinical trial notification (CTN) scheme and have made an application for GMP certification of the manufacturing site before the end of the transition period (i.e. by 30 June 2019) you may continue to supply without satisfying the GMP requirements under Part 3-3 of the Therapeutic Goods Act 1989, until a decision is made on your application. You would need to be ready for an inspection of the manufacturing site at any time following submitting the application for GMP compliance, which would generally occur between 2-6 months from when the application was made.

  • CTX application. Where an autologous HCT product is being supplied as part of an approved HREC clinical trial for a Class 4 biological prior to 1 July 2018, and the recruitment and supply of the product will not be completed by 30 June 2019.

    If you submit a CTX application before the end of the transition period (i.e. by 30 June 2019) you may continue to supply without satisfying the requirements for inclusion in the ARTG under Part 3-2A and the GMP requirements under Part 3-3 of the Therapeutic Goods Act 1989, until a decision is made on your application. Where the trial is not 'first-in-human', GMP certification of the manufacturing sites must be sought during the transition and approved before the CTX application can approved.

  • Inclusion on the ARTG. Where an autologous HCT product is being supplied, but there is the intent to transition to supply following inclusion in the ARTG.

    Where an application for inclusion in to the ARTG has been made and it has successfully completed preliminary assessment before the end of the transition period (i.e. by 30 June 2019) you may continue to supply without satisfying the requirements for inclusion in the ARTG under Part 3-2A and the GMP requirements under Part 3-3 of the Therapeutic Goods Act 1989, until a decision is made on your application. Note that an application for a GMP licence or certificate of the manufacturing sites must be sought during the transition and obtained before the application can be approved.


Version history
Version Description of change Author Effective date
V1.0 Original publication

Biological Science Section

Regulatory Guidance Team

July 2018