LS&HC Horizons 2023 - Flipbook - Page 56
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | APAC
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Cell, tissue and gene therapies: regulatory challenges
and responses in Australia
In July 2022, the Australian Therapeutic Goods
Administration (TGA) published a report
reflecting stakeholder review of issues and
roadblocks in the cell, tissue, and gene therapy
(CTGT) space, as well as TGA’s proposed
responses. The report identified several pain
points, including: increased certainty
and clarity in the CTGT clinical trials
process; need for clear patient access
pathways; and communication between
regulators and parallel processing.
In response, TGA has taken actions, including:
• Introduction of a priority review
pathway for biologicals: The priority
review pathway for biologicals was
introduced on 1 October 2022. Under
new Part 3D of the Therapeutic Goods
Regulations 1990 (Cth), novel biologicals
intended for the treatment, prevention, or
diagnosis of a life-threatening or seriously
debilitating condition may be eligible to
apply for expedited assessment and inclusion
on the Australian Register of Therapeutic
Goods (ARTG);
• Completion of a consultation on a
pathway to approve ‘export only’
biologicals: It is proposed to allow
suppliers of biologicals (e.g., CTGT products)
to export overseas with different indications
to their Australian counterparts, assisting
with the commercialization of such products.
Mandi Jacobson
Partner, Sydney
Proposed amendments to the Therapeutic
Goods Act 1989 (Cth) and Therapeutic
Goods Regulations 1990 (Cth) to allow for
the ‘export-only’ pathway were introduced
on 1 December 2022 (but has not yet been
passed by Parliament);
• Initiating review of the Clinical Trial
Approval (CTA) pathway: Including
educational campaigns regarding timeframes
and processes;
• Commencing discussions with
the Office of the Gene Technology
Regulator (OGTR): To review interactions
around genetically modified organisms and
revise guidance material published by both
regulators; and
• Engaging a Digital Transformation
Project: Including support for the National
One Stop Shop (a national online platform
that will combine all agencies involved in
clinical trials in one place).
It is clear that regulatory changes in the form
of new approval pathways are on the horizon.
Companies intending to conduct clinical
trials in Australia should keep abreast of
any changes.
Angell Zhang
Senior Associate, Sydney
