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  • 1.  Japan Foreign Manufacturer Accreditation Renewal

    This message was posted by a user wishing to remain anonymous
    Posted 20-Jan-2022 13:58
      |   view attached
    This message was posted by a user wishing to remain anonymous

    Hello-
    I am looking for guidance / feedback on the renewal process for the Japanese Foreign Manufacturer Accreditation. According to the attached document I found on the PMDA website, it sounds like all I need to submit for renewal is the completed Form 20- Application for Renewal... and our current certificate. Is the correct? Also, where exactly do I send the application information? Is it to the fax number under section 2-1- 



    Any feedback / guidance would be greatly appreciated

    Attachment(s)

    pdf
    PMDA Guidance on Application of Accreditation.pdf   181 KB 1 version


  • 2.  RE: Japan Foreign Manufacturer Accreditation Renewal

    Posted 21-Jan-2022 03:41

    In principle, application for Accreditation of Foreign Manufacturers is supposed to be made by a Japanese marketing approval holder who markets your drug in Japan. I recommend that you consult with your Japanese partner first.

    For your information, regarding the attached document for the renewal application, you need to submit the forms of "outline of buildings and facilities", "utilization of other testing and inspection facilities" and "outline of buildings and facilities of sterile products" in addition to the original copy of accreditation document and the Form No.20.  Please note that the forms require many attachment documents.

    Also, the fax number you referred is just for brief consultation and not for submission. Submission can be made at the registration counter in PMDA or a mail (not an e-mail).

    I hope this  helps.

    Toru



    ------------------------------
    Toru Murakumo RAC
    Director, Regulatory Science Department, EPS International
    Suita-shi
    Japan
    ------------------------------

    Original Message


  • 3.  RE: Japan Foreign Manufacturer Accreditation Renewal

    This message was posted by a user wishing to remain anonymous
    Posted 21-Jan-2022 11:53
    This message was posted by a user wishing to remain anonymous

    Toru-
    Thank you for the information.  I have the facility photos as you mention, but when you say FRM 20 requires a lot of attachment documents, what do you mean? Can you point me to another document that has this information?

    Many thanks!
    Original Message


  • 4.  RE: Japan Foreign Manufacturer Accreditation Renewal

    Posted 24-Jan-2022 01:27

    The form No 20 itself does not require many attachments.  But other forms or documents such as "outline of buildings and facilities", "utilization of other testing and inspection facilities", and "outline of buildings and facilities of sterile products" require attachments. For example, floor plan of the relevant facilities, list of type and number of equipment and utensils used to manufacture the products, list of testing and inspection equipment and utensils, etc. Columns for such information is provided in the forms but you need to prepare attachment as space on the form is quite limited. This information is provided in the PMDA Japanese website but the English guidance which you picked out of PMDA English website is just an overall summary and does not include specific documents or forms.

     

    Following is the relevant page of the PMDA Japanese website and the renewal of Foreign Manufacturer Accreditation is mentioned in section 2(4).

    https://www.pmda.go.jp/review-services/drug-reviews/foreign-mfr/0009.html

     

    Documents to be attached to the form No.20 are listed No.1-4.  No. 1 is the original copy of the accreditation certificate. No. 2-4 are other documents I mentioned above.  Please go to the hyperlinked documents.  They have English translation and you can see what is necessary. You can submit renewal application form No. 20 with these documents.  As the standard review time for renewal is 5 months, you may need to submit renewal at least 5 months before the current accreditation expires.

     

    Hope this helps.

    Kind regards,

    Toru

     

     

    Toru Murakumo, RAC

    Director, Regulatory Science Department

    Business Operations Headquarters

    EPS International

    Tel: +81-70-3078-1789

     




    Original Message


  • 5.  RE: Japan Foreign Manufacturer Accreditation Renewal

    This message was posted by a user wishing to remain anonymous
    Posted 25-Jan-2022 10:44
    This message was posted by a user wishing to remain anonymous

    Thank you again for the information, it has been very helpful!
    Original Message


  • 6.  RE: Japan Foreign Manufacturer Accreditation Renewal

    Posted 25-Jan-2022 18:30

    Please note that the documents should be written in Japanese.  From that point as well, I would recommend you to consult with the Japanese market authorization holder of your product.

     

    Best regards,

    Toru

     

    Toru Murakumo, RAC

    Director, Regulatory Science Department

    Business Operations Headquarters

    EPS International

    Tel: +81-70-3078-1789

     




    Original Message


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