Biologicals regulatory framework changes from 1 July 2018

Including changes to regulation of autologous human cell and tissue products and classification of biologicals

2 July 2018

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Transition arrangements

From 1 July 2018, transitional arrangements will apply to autologous HCT products currently excluded from regulation by the TGA under item 4(q) of the Therapeutic Goods (Excluded) Order that will not meet the conditions for exclusion or exemptions under the new arrangements. During the transition period certain autologous HCT products may be exempt from:

  • using 'unapproved' product pathways (e.g. clinical trials under CTN route, Special Access schemes)
  • requiring inclusion on the ARTG
  • holding evidence that the manufacturing facility satisfies good manufacturing practice (GMP) requirements. (The exemption from GMP requirements also applies to any contracted testing facilities used, e.g. for sterility testing.)

All other regulatory requirements will apply to these autologous HCT products from 1 July 2018, such as:

Any autologous HCT product stored beyond the transition period, which do not comply with the new requirements, including manufacturing in a GMP licences 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.

At any time during the transition period an application can be made for GMP certification of a manufacturing site, a clinical trial exemption (CTX) or for inclusion of your autologous HCT product in to the ARTG.

When transitional arrangements apply

The transitional arrangements may apply in specific circumstances, including:

  • when autologous HCT products have been supplied before 1 July 2018 (including clinical trials)
  • where the intent is to submit an application for GMP certification, a CTX or inclusion in the ARTG.

Autologous HCT product supplied before 1 July 2018 (including clinical trials)

Where an autologous HCT product has been supplied prior to 1 July 2018 this can continue until 30 June 2019. This is intended to allow patients that have been scheduled for treatment to complete the procedure. Similarly, any clinical trials (CTN or CTX) that have been approved by a HREC and are underway prior to 1 July 2018 can continue, but patient treatment must be completed by 30 June 2019.

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

Note that the following requirements will still apply:

Where the intent is to submit an application for GMP certification, a CTX or an application 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 HREC-approved 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.
  • Where the trial is not 'first-in-human', GMP certification of the manufacturing sites must be sought during the transition and obtained before the CTX is approved.
  • 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 Act, 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 obtained before the CTX is approved.
  • Inclusion on the ARTG. Where an autologous HCT product is being supplied, but there is the intent to transition from supply under the current exclusion to supply following inclusion in the ARTG. Where an application for inclusion in to the ARTG has been made and 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 Act, until a decision is made on your application. Note that GMP licencing or certification of the manufacturing sites must be sought during the transition and obtained before the application can be approved.

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