Regulatory Open Forum

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  • 1.  Analytical Methods for AUS Clinical Studies

    Posted 11 days ago

    My company is likely to hold clinical trials for our vaccine candidate in AUS. I took a look at the TGA website and it says they align with EP, USP, and ICH guidelines. Obviously there is some overlap between the guidances and some differences in terms of stringency in requirements. We are developing analytical methods for the clinical study material and are wondering if AUS will except conformance to any of those three guidances or expects the most stringent? Can anyone help me with this?


    Kristen Boles
    Manager QC Validation/Method Transfer
    Rodeo CA
    United States

  • 2.  RE: Analytical Methods for AUS Clinical Studies

    Posted 6 days ago
    I'm having a hard time thinking of a scenario where there might be a discrepancy among the different guidelines you cited, so I wonder if you have a specific situation in mind.

    In general, when you're talking about the analytical methods for specific tests, like sterility or endotoxins, ICH guidelines don't really speak to that. In that situation, if you do have a method that complies with, for example, EP but not USP, I have never seen an issue for Australia, i.e., they'll accept either.

    If you're talking about the battery of tests on the specification, I think you always have the option to justify your specification. If a monograph exists in either EP or USP (I think that's more likely in EP), then at the commercial stage TGA will at least ask about it if you don't fully comply. I've very rarely seen CMC questions from TGA on clinical applications, so I doubt it would be an issue at this stage (with the caveat that my vaccine experience is now 10 yrs old).

    I might be able to give better advice if you had a more specific question.

    Rachel Thornton
    Associate Director
    Smyrna GA
    United States