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  • 1.  Is EU Dossier of Generic Product acceptable to HC for filing ANDS?

    Posted 15-Sep-2013 10:09
    Can someone tell me if EU Dossier filed for a Generic Oral Solid Dosage product would be suitable for filing or be acceptable for ANDS filing with Health Canada Agency? This product would have minimum of 6 months' stability data (Meeting Region 4 stability) on three Regulatory submission batches and BE studies done with EU RLD.  It is assumed that EU RLD and Canadian RLD are manufactured at the same facility.

    Thanks

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    Shirish Shah, Ph.D. 
    Phoenix AZ
    United States
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  • 2.  RE:Is EU Dossier of Generic Product acceptable to HC for filing ANDS?

    Posted 15-Sep-2013 16:04

    Although EMA adopted ICH guidelines, actual implementation may differ in practice.  

    I think you may be in a better position to compare more accurately between your data available and the requirements for Health Canada based on the information below.  

    Regulatory requirements for generics in Canada

    The testing requirements for generics are the same (generics v. innovator drug, reference product).

    • ICH guidelines (recommended to follow) have been endorsed by H. Canada.

    As for drug substance, the minimum stability data requirements are:

    • 2 batches, minimum pilot scale, 6 months long term, 6 months accelerated under ICH storage conditions. 
    As for drug products,
    • The biobatch pilot scale (1/10 of full production scale or 100,000 units, whichever is larger, or JUSTIFICATION to support your request of waiver?).
    • At least two unique batches of each strength at minimum pilot scale (e.g. one-tenth of full production scale or 100,000 units, whichever is larger).
    • For solid oral dosage forms: comparative dissolution profiles (with JUSTIFICATION for the dissolution method) for all generic strengths not used in a comp BA study.
    • The minimum stability data requirements: 6 months long term, 6 months accelerated under ICH storage conditions.

    Read more at http://wp.me/P33LGu-1f8

    BTW:  when you say Region 4, are you referring to test conditions (30C and 65% RH or 30C and 75% RH)? 


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    President and Principal
    http://www.regulatorydoctor.com
    Riner VA
    United States
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    Original Message


  • 3.  RE:Is EU Dossier of Generic Product acceptable to HC for filing ANDS?

    Posted 16-Sep-2013 09:31
    Since there is a MRA (mutual recognition agreement) between the EU and Canada, it may work. 

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    Catherine Bernard PhD
    Pres
    International Regulatory Affairs Services Inc
    Highlands Ranch CO
    United States
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    Original Message


  • 4.  RE:Is EU Dossier of Generic Product acceptable to HC for filing ANDS?

    Posted 16-Sep-2013 15:44
    Hello Shirish,

    As far as i know your generic drug must be equivalent to Canadian listed reference product as per C.08002.1.
     I agree that both the RLD can be manufactured at the same facility but they must listed via two different drug application(EU and Canada). and your test product must be equivalent to Canadian reference listed drug.

    Best Regards

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    Amit Jain
    United States
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    Original Message


  • 5.  RE:Is EU Dossier of Generic Product acceptable to HC for filing ANDS?

    Posted 17-Sep-2013 11:43
    Hello Shirish,

    To determine whether a particular EU dossier (generic oral dosage form) would be acceptable to file with Health Canada, you should really have a detailed gap analysis performed.  There are important several factors to consider beyond some of the obvious ones such as stability.  For example: the Reference Product must meet the very specific requirements for a Canadian Reference Product (as per HC's policy), there must be a valid Certificate of Compliance issued by the HC Inspectorate for all foreign manufacturing facilities prior to the submission being accepted for review (a relatively new and onerous requirment), and any referenced DMF must alreaady be filed with Health Canada. 

    In working with such EU dossiers recently, I have also found that other common deficiencies include the lack of appropriate quality specifications for the drug substance, and a lack of required analytical method validation.

    So, in summary, I suggest you consider a thorough assessment of the dossier before filing, so you don't get surprised during review (and possible face a forfeit of at least part of the submission fee).

    Regards,

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    Stan North
    President / Consultant
    Montreal
    Canada
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    Original Message