While FDA currently still accepting paper submissions, effective May 5, 2017, FDA will require that the following be submitted in eCTD format:
- Drug Master File (DMF)
- New Drug Applications (NDA)
- Abbreviated New Drug Applications (ANDA)
- Biologics License Applications (BLA)
- Investigational New Drugs (IND) – Unless for non-commercial products (starting May 2018)
- Combination Products
It is FDA’s intent that submitted data be both compliant and useful for their reviewers. In FDA’s words, the data should conform to the applicable and required data standards. While it is not necessary to resubmit items previously submitted in paper, FDA will reject any submissions after May 5, 2017 that are not compliant.
Companies should begin preparing for this transition by thinking through their options for conversion to FDA’s required eCTD granularity. EAS provides eCTD writing services and can assist your company in submitting eCTDs.
There are various options for submitting documents to EAS for conversion into eCTD format:
- You may submit one entire DMF, untabbed, and EAS will separate the document into appropriate sections for submittal. FDA has required specifications for the formats, hyperlinks, and tables of contents. EAS consultants can ensure your PDF documents are appropriately broken down and placed into folders and subfolders such as Toxicology, Pharmacology, etc. per FDA regulations. Sections of the eCTD are then converted into XML (Extensible Markup Language) which enables FDA to see the basics of the submission, such as the sponsor, the application, the submission and sequence number.
- You may also choose to submit your documents as individual PDF files, already broken down by category. If this is the case, EAS Consultants can verify that the documents are broken down appropriately and then convert into the required eCTD format prior to submission.
Once in proper form, EAS may submit the eCTD on your company’s behalf, or send the submission back to you to submit through FDA’s required gateway.
Please contact EAS with your eCTD questions. As always, EAS is available to review your submissions prior to sending to FDA to ensure compliance and completeness. This will expedite FDA’s review.