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
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).
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.
Toru Murakumo, RAC
Director, Regulatory Science Department
Business Operations Headquarters
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.
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