G/TBT/N/AUS/138  
2 March 2022  
(22-1935) Page: 1/2 
Committee on Technical Barriers to Trade  Original:  English  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member:  AUSTRALIA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible:  Therapeutic Goods Administration, Department of Health  
Name and address (including telephone and fax numbers , email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if d ifferent from above:   
Department of Foreign Affairs and Trade  
Email: tbt.enquiry@dfat.gov.au  
3. Notified under Article 2.9.2 [X], 2.10.1 [   ], 5.6.2 [   ], 5.7.1 [   ], other :  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable):  Products 
regulated by the Therapeutic Goods Administration (TGA) as 'biologicals' including human 
tissue -based products (e.g., skin, bone,  ocular, cardiovascular donor tissue); cell -based 
products (e.g., genetically modified cells); immunotherapy products containing 
genetically engineered human cells (e.g., CAR -T cells); products that comprise or contain 
live animal cells, tissues or organs (e.g., pancreatic islet cells isolated from pigs); 
autologous human cell and tissue (HCT) products (e.g., human stem cell transplants); 
and faecal microbiota transplant (FMT) products.; PHARMACEUTICAL PRODUCTS (HS 30)  
5. Title, number of pages and languag e(s) of the notified document:  Priority Review 
pathway for biologicals: feasibility, potential eligibility criteria and determination process 
(21 page(s), in English)  
6. Description of content:  Australia's Therapeutic Goods Administration (TGA) is seeking  
feedback on a proposed priority pathway for assessment of certain novel and life -saving 
biologicals .  
The proposed 'Priority Review' pathway will align with the pathway already in place for 
medicines and offer a faster formal assessment pathway for biologicals in certain 
circumstances. This will allow consumers with life -threatening diseases or seriously 
debilitating conditions to access these treatments in less time if the assessment results  
in a decision by the TGA to include the biological in the Australian Register of Therapeutic 
Goods (ARTG) . 
Australia does not currently have a formal mechanism to expedite the assessment and 
inclusion of biologicals in the ARTG. Depending on the feedback received, the TGA could 
propose to the Australian Government that a priority pathway be implemented for the 
pre-market assessment and registration of novel biologicals that address unmet clinical 
needs for Australian consumers. This would require changes to the Therapeutic Goods 
Regulations 1990 . 
The TGA is conducting a public consultation on the proposed pathway between February 
2022 and March 2022 to seek feedback on:  G/TBT/N/AUS/138  
 
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  • whether stakeholders support introduction of such a pathway  
• eligibility criteria for the Priority Review pathway for biologicals  
• the Process for determining whether a biological application meets the eligibility 
criteria for Priority Review (the 'Determination Process').  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the propo sed Priority Review pathway are to:  
• assist in achieving a faster assessment and earlier access to certain novel and 
life-saving biologicals that address unmet clinical needs for Australian 
consumers, bringing these to market faster than using standard evaluation 
pathways  
• provide timely and flexible registration processes for sponsors seeking access to 
the Australian market for new and novel uses of biologicals that offer substantial 
benefits to Australian consumers  
• increase alignment with other  overseas regulators that offer accelerated 
assessment processes.  
Protection of human health or safety; Harmonization  
8. Relevant documents:   
The consultation paper on the proposed Priority Review pathway is available at 
https://consultations.tga.gov.au/medicines -regulation -division/priority -review -pathway -
for-biologicals . This document outlines the proposed eligibility criteria, determination 
process and other considerations including fees and charges.  
9. Proposed date of adoption:  If supported by stakeholders, the TGA could propose to 
the Australian Government to introduce the pathway within the next 12 months.  
Proposed date of entry into force:  If supported by stakeholders, the TGA could 
propose to the Australian Government to introduce the pathway within the next 12 
months.  
10. Final date for comments:  60 days from notification  
11. Texts available from:  National enquiry point [ ] or address, telephone and fax 
numbers and email and website addresses, if available , of other body:   
https://consultations.tga.gov.au/medicines -regulation -division/priority -review -pathway -
for-biologicals