Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017. In an advanced notice, it has also come to notice that Health Canada (HC) is considering to make eCTD format mandatory by January 1st, 2018. As the drug makers across the world are waking up to the fact that they should do away with the legacy paper document submissions adhering to the HA regulations, let us give you a quick roadmap towards successful eCTD submissions.

eCTD – the definition and the purpose

According to ICH, the eCTD is an interface for industry to agency transfer of regulatory information while at the same time taking into consideration the facilitation of the creation, review, life cycle management and archiving of the electronic submission. The eCTD provides a harmonized technical solution to implement the Common Technical Document (CTD).

The main purpose of this technical solution is to make the Regulatory submissions easier with a common global standard enabled for all drug makers which indeed can streamline the Regulatory submissions to health authorities.

Countries accepting eCTD format

Now eCTD has become a global submissions format. The countries which are accepting eCTD submissions are:

  • US FDA
  • European Medicines Agency (EMA)
  • Japan
  • Health Canada
  • Swissmedic
  • China eCTD adoption

Which applications should be in eCTD format?

As US FDA mandates drug makers who are willing to file the below applications should follow eCTD format:

  • New Drug Applications (NDAs) – 5th May 2017
  • Biologics License Application (BLAs) – 5th May 2017
  • Abbreviated New Drug Applications (ANDAs) 5th May 2017
  • Investigational New Drug Applications (INDs) – 5th May 2018

For Health Canada, the following applications are considered to be mandatory for filing in eCTD format:

  • New Drug Submission (NDS) – Jan 1st, 2018
  • Supplement to a New Drug Submission (SNDS) – Jan 1st, 2018
  • Abreviated New Drug Submission (ANDS) – Jan 1st, 2018
  • Supplement to an Abreviated New Drug Submission (SANDS) – Jan 1st, 2018
  • Additional information or subsequent regulatory activities viz. NC, PSUR, RMP, etc. must also be filed in eCTD format – Jan 1st, 2018

Why should you adopt eCTD?

  • For reviewers, it saves a lot of time in order to search and edit the submissions with automated functionalities
  • For sponsors, the cost would be reduced as they will not be required to physically ship the documents and create new documents, if any amendments needed
  • With its global standardized format, eCTD can be repurposed for Regulatory submissions to different agencies thus, the enables cost savings

To conclude, electronic submissions are the order of the day. However, Drug makers are not on the verge of deadlines. With a little time in hand, chalk out your region-wise eCTD submissions plan for faster drug approvals. Consult an exclusive Regulatory Submissions & Publishing partner.


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