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  • 1.  Review/approval of CTA in Australia to commence Phase 1

    This message was posted by a user wishing to remain anonymous
    Posted 05-Nov-2020 09:24
    This message was posted by a user wishing to remain anonymous

    We would like to conduct Phase 1 studies in Australia in Healthy Volunteers. Any advice on how long it takes for the review/approval of the CTA? I have heard that the CTA package of information is "lighter" than what's required for an IND. Any insights on the content of the CTA for the TGA submission, particularly the nonclinical data?
    Greatly appreciate any advice/guidance/suggestions.


  • 2.  RE: Review/approval of CTA in Australia to commence Phase 1

    Posted 06-Nov-2020 07:48
    Hello, 
    I have a number of clients with Clinical Trials in Australia.  With a newer streamlined regulatory environment, they continue to be a preferred location for early stage trials.  I have seen a single review cycle in 6-8 weeks, but know it can depend on the state as well.  The aspect we assist clients with is around the clinical trial insurance required by the ethics board.  We see a number of "sponsors" of early stage unaware of teh 20M AUD requirement in New South Whales, but we also see a number of our CRO clients engage as the sponsor locally in conjunction with the innovator as well.  Hopefully that is helpful. 


    ------------------------------
    Scott McMahon
    Life Sciences Practice Leader - MW Region
    Willis Towers Watson
    Scott.McMahon@willistowerswatson.com
    ------------------------------

    Original Message


  • 3.  RE: Review/approval of CTA in Australia to commence Phase 1

    Posted 10-Nov-2020 00:09
    Hi Anon,

    Australia's TGA has two routes for clinical trial oversight.  CTN ("notification") and CTA ("approval", which was TODAY renamed from the old CTX "exemption").

    • CTA (used to be CTX) requires a TGA submission and review.  It's a similar process to a US FDA IND/IDE process for significant risk devices.
    • CTN is a notification only, similar to a non-significant risk IDE.

    Point is that CTA (CTX) is really only used for later stage and substantial trials for prescription medicines.  It's rarely used for early trials for medicines and never used for medical devices.

    For your study a CTN is likely all that is needed.  The process is straightforward, inexpensive (notification fee around USD 250) and is contingent on ethics committee sign off of the CTN paperwork.

    Let me know if you need local assistance including a referral to an appropriate CRO.

    Meanwhile check out https://www.tga.gov.au/clinical-trials 




    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    www.brandwoodckc.com
    ------------------------------

    Original Message


  • 4.  RE: Review/approval of CTA in Australia to commence Phase 1

    Posted 06-Nov-2020 08:03
    There are two regulatory schemes to approval of a healthy volunteer study in Australia, clinical trial notification (CTN) and clinical trial exemption (CTX). The main difference between the CTN and CTX schemes is TGAs level of involvement in reviewing data about the therapeutic goods before the clinical trial commences.

    The choice of which scheme to use (CTN or CTX) lies firstly with the trial sponsor and then with the human research ethics committee (HREC) that approves the protocol (except for certain Class 4 biologicals, which must be approved under the CTX scheme).

    One of the determining factors for a HREC is whether the committee has access to appropriate scientific and technical expertise in order to assess the safety of the product. The approving authority takes the ultimate responsibility for determining whether the trial is allowed to proceed at the site.

    I could go on and on - but simply stated the vast majority of clinical trials can be approved by the HREC and notification to TGA based on the little more than the protocol and investigators brochure. TGA provides excellent guidance on their website (https://www.tga.gov.au/clinical-trials)

    Furthermore, don't forget the significant rebate available from the government for clinical trials performed in Australia.

    ------------------------------
    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    New York NY
    United States
    ------------------------------

    Original Message


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