Regulatory authorities globally have implemented systems to review submissions in eCTD format.  FDA CDER has required eCTD format since January 1, 2008.  The European Medicines Agency (formerly EMA) has required eCTD format for submissions using the centralised procedure since January 1, 2010.  FDA CBER is insisting on eCTD format for BLA submissions under priority review or using the rolling submission process.

What could possibly go wrong with your eCTD?

...Plenty!

Every regulatory authority receiving eCTD submissions performs a programmatic validation of compliance with the eCTD standards. If any aspect of your submission fails validation – your submission must be corrected and resubmitted. The review clock doesn’t start until you submit a valid eCTD.

Once the review clock starts, the regulatory authority can still Refuse to File (RTF) your eCTD if there are deficiencies related to navigability of the files, incompatible formats, dead or missing bookmarks and hyperlinks, missing datasets, or inadequate organization. So your eCTD submission faces several hurdles before a review actually commences. Any aspect of noncompliance of your eCTD submission will impact time-to-market, competitiveness, and product revenues. The time and cost of remediating the noncompliance has been formidable.

FDA in concert with international standards organizations is developing the follow-on format – called Regulated Product Submission (RPS) – that builds on the eCTD standard. RPS will impact all companies that are regulated by any center of FDA – drugs, biologics, devices, food, cosmetics, veterinary, and tobacco. What do you need to do to prepare for RPS?

e-SubmissionsSolutions.com offers consulting services, training, coaching, staff augmentation, and outsource publishing services to help you deliver clean, compliant, accurate eCTD submissions and prepare for the upcoming RPS format.

In addition, e-SubmissionsSolutions.com offers MS Word templates in all forms of eCTD granularity guaranteed to produce compliant PDF files through www.SageSubmissions.com.