Regulatory Open Forum

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  • 1.  Labeling Requirements for APIs Used in Clinical Trials and Transition to Commercial Use

    This message was posted by a user wishing to remain anonymous
    Posted 12 days ago
    This message was posted by a user wishing to remain anonymous

    My company manufactures APIs used exclusively for clinical trials. According to ICH Q7 guidelines, "Labeling for APIs intended for use in clinical trials should be appropriately controlled and should identify the material as being for investigational use." I have two questions:

    1. Should specific terminology appear on the label to comply with these guidelines?
    2. Once we begin supplying to a commercial manufacturer, should we update the label to remove the investigational use statement?



  • 2.  RE: Labeling Requirements for APIs Used in Clinical Trials and Transition to Commercial Use

    Posted 11 days ago

    Hello,

    Yes, you need to have on the label text to say that it is for clinical investigation only. The exact text vary between countries so you better check with each country where you will be supplying the device. 

    Usually there are 2 scenarios:

    1. If the device is not commercial or is manufactured only to be used in a clinical trial then you need to have on the label the statement that it is for clinical investigation only.
    2. If the device is a commercial product and has a label already you will need to add additional label to indicate that it is for use in clinical investigations. 

    Depends on the device type you will need to decide what is the best place to place the label but the main point is that the device has to be clearly labelled that it is for clinical investigations only.

    Good luck with your study.

    Olga



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    Olga Peycheva
    Regulatory and Study Start Up Specialist (Clinical trials)
    Solutions OP Ltd
    https://solutionsop.co.uk/
    United Kingdom
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  • 3.  RE: Labeling Requirements for APIs Used in Clinical Trials and Transition to Commercial Use

    Posted 10 days ago

    1) You need to comply with 21 CR 312.6 including having the statement "Caution: New Drug - Limited by Federal (or United States) law to investigational use." on your label.

    2) Once drug is approved and you are supplying API to a commercial manufacturer you can remove the statement.



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    Tom Stothoff
    Senior Director, Regulatory Affairs CMC
    Chicago
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  • 4.  RE: Labeling Requirements for APIs Used in Clinical Trials and Transition to Commercial Use

    Posted 10 days ago

    Regulations specify that drug product be labeled for clinical investigations and various regulatory authorities have required language that may differ by region. I am not aware of specific terminology for API labeling other than what is needed to identify/connect the contents of the container to the batch record and the general statement that API meant to be used in manufacture of drug product for clinical trials be labeled for investigational use, particularly if being exported or imported. Not all API is used in manufacture of drug product but destined for stability studies, R&D, etc. Labeling of API is under the control of the Quality Management System.



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    Glen Park PharmD
    Consultant
    Burien WA
    United States
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