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  • 1.  API Canadian DMF

    Posted 08-Feb-2012 10:34
    Hi All,

    Is it mandatory to submit a Canadian DMF for an API? For instance, I would like to change the manufacturing site (new manufacturer) and wonder if the new manufacturer needs to have a Canadian DMF.

    Thank you.

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    Tom Namsavanh RAC
    Regulatory Affairs Specialist
    ERFA Canada Inc.
    Montreal QC
    Canada
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  • 2.  RE:API Canadian DMF

    Posted 09-Feb-2012 14:37

    Hi Tom,

    It is not mandatory to submit a DMF but without one, the manufacturer will have to provide detailed manufacturing information to the sponsor. A DMF is often preferred when an API manufacturer wishes to protect its information rather than share it with the sponsor.

    When a DMF is filed, Health Canada will direct its questions on the restricted portion of the DMF directly to the API manufacturer, and not the sponsor.

    If the manufacturer of the API is also the sponsor, this may not be deemed necessary.

    Regards,

    -------------------------------------------
    Elodie Martin
    Regulatory Associate
    Hospira
    Saint-Laurent QC
    Canada
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    Original Message


  • 3.  RE:API Canadian DMF

    Posted 09-Feb-2012 15:24
    Hi Tom,

    For Health Canada, it is optional for the drug sponsor to reference a DMF for the drug substance when filing their NDS.  There are certain advantages for an API supplier to use a DMF when dealing with clients, of course, but certainly not mandatory. 

    Hope that helps.

    -------------------------------------------
    Stan North
    Stan North Consultation
    Montreal
    Canada
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    Original Message


  • 4.  RE:API Canadian DMF

    Posted 10-Feb-2012 08:04
    Dear Tom,

    Yes it is required if you want to change the vendor of API source. Then that Vendor should have a Canadia DMF with TPD. If the new vendor has got CEP granted by EDQM on the subjected API (with identical process & controls etc..), then they can also submit it using attenstations along with the Canadian DMF to expedite the process. As in this case closed part is not revied by TPD only Applicants part included in application is reviewed. So this reduces the 1st round queries.
    Hope it helps.

    Regards, 
    -------------------------------------------
    Sushil Sharma
    Uttar Pradesh
    India
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    Original Message


  • 5.  RE:API Canadian DMF

    Posted 10-Feb-2012 09:42
    Tom,
    if you are only changing your manufacturing site, but the process and release testing stays the same, you may be able to refer to this as a site change.  if your API process description is already in your product file, you can indicate that the site of manufacture has changed but nothing else.  The new site will have to have approval to sell into the Canadian market, so you will have to supply proof of GMP compliane, and possibly a site file.

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    Mary Todas RAC
    Regulatory Affairs Manager
    Kalamazoo MI
    United States
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    Original Message


  • 6.  RE:API Canadian DMF

    Posted 11-Feb-2012 12:11

    Thanks Mary for your valuable update. But i guess Tom is changing the vendor (New manufacturer) not the transferring the API to their new manufacturing site.

    So I guess if new API manufacturer has to be switched from the existing one, then the new API vendor must have their file with TPD, for evaluation of CMC of new vendor's API while assessing the sANDS etc..
    Regards,
    -------------------------------------------
    Sushil Sharma
    Uttar Pradesh
    India
    -------------------------------------------






    Original Message


  • 7.  RE:API Canadian DMF

    Posted 10-Feb-2012 13:44
    Thank you everyone for your inputs. I really appreciate your prompt replies, and wisdom.

    Sincerely,
    -------------------------------------------
    Tom Namsavanh RAC
    Regulatory Affairs Specialist
    ERFA Canada Inc.
    Montreal QC
    Canada
    -------------------------------------------






    Original Message


  • 8.  RE:API Canadian DMF

    Posted 11-Feb-2012 12:01
    Also please consider the following:

    Per Draft Guidance Documents on DMFs, please see the section "2.2.4.1 Amendments," the relevant part of which is copied and pasted below for your convenience. 

    2.2.4.1 Amendments

    Amendments are changes to a DMF and include trade name changes, DMF name changes, manufacturing site or manufacturing process changes or addition of a manufacturing site. Technical and administrative amendments should be filed separately with changes highlighted where appropriate (e.g. in a side by side comparison). Amendments should be submitted at the earliest opportunity when they pertain to the quality of a component described in a DMF in accordance with the applicable guideline on changes to marketed products, e.g. Changes to Marketed New Drug Products.

    A single copy of the amendments should be submitted, together with a signed original of the covering letter and a copy thereof. The covering letter should clearly indicate the DMFnumber, the Health Canada file number, the type of DMF (I, II, III or IV) and the sections of the DMF affected by the amendments. The form "Drug Master File Application" should accompany all amendments.

    Amendments found in a Sponsor's submission are not added to the DMF. New data provided to the Sponsor by the DMF Owner should also be filed with the DMF.



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    David Lim, Ph.D., RAC, ASQ-CQA
    Chairman and CEO
    www.regulatorydoctor.com
    Floyd VA
    United States
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    Original Message