FDA and Health Canada plow ahead with eCTD requirements

The road to implement monumental changes which affect all segments of an industry is often full of roadblocks and milestone achievements, and the move to a fully electronic submission system requiring mandatory e-filing has been no different. For North America’s major regulatory agencies, FDA and Health Canada, this transition is moving forward with industry needing to make strategic investments to keep up.

For Health Canada an important milestone was reached through collaboration with the FDA to utilize their established electronic submissions gateway (ESG) as a funnel for Canadian eCTD submissions. Health Canada now requires that all e-submissions greater than 10 GB be submitted via the gateway. Further, both the FDA and Health Canada have published effective dates for industry to submit applications in eCTD format only. While the FDA has already implemented the requirement that all NDAs, ANDAs, and BLAs be submitted electronically (May 5, 2017), Health Canada has set their implementation date for mandatory electronic NDSs, SNDSs, ANDSs, SANDSs and their lifecycle submissions as January 1, 2018.

For many companies, large and small, these changes to the submission process represent large administrative and budgetary hurdles. Evaluating e-publication systems and implementing one in-house, while hiring or training qualified staff to manage the process presents a large drain on company resources.

Fortunately the average cost to outsource the formatting and e-publication of an existing or new dossier and ongoing lifecycle submissions is far less than the cost to hire staff and purchase an in-house system. Since Regxia’s founding in 2007 we have compiled, validated and submitted over 5000 e-submissions (base submissions and lifecycle sequences) on behalf of our clients to Health Canada and the FDA. Regxia has also assisted many companies to transition to their own system while remaining as an ongoing resource.

We invite you to meet us at the DIA 2017 Annual Meeting Booth 1351 (18-22 June 2017, Chicago, IL). And at RAPS Regulatory Convergence Booth 336 (9-13 September 2017, National Harbor, MD) to discuss how we can assist you in solving the challenges faced by these new e-submission requirements.

To register as a one day attendee or for the full conference at the DIA   http://www.diaglobal.org/en/flagship/dia-2017/about/register

To register as a one day attendee or the full conference at RAPS   https://www.raps.org/cr.aspx?id=27018

Let our experience dealing with the agencies and the reviewer’s preferences streamline your conversion to eCTD and the submission process.

It’s here! CDER and CBER will only accept eCTD for new NDAs, ANDAs, and BLAs.
http://regxia.com/blog/its-here-cder-and-cber-will-only-accept-ectd-for-new-ndas-andas-and-blas/

Health Canada Confirms Plans for Mandatory Filing in eCTD format
http://regxia.com/blog/health-canada-confirms-plans-for-mandatory-filing-in-ectd-format/

About Regxia Inc.
Regxia Inc. is a unique scientific and regulatory consulting firm serving the pharmaceutical and biotech industries. Regxia focuses on fostering long-term client relationships based on trust, reliability and common values. Regxia offers a full range of Regulatory Services to support client products at all stages of development, from concept to launch and through its lifecycle. Regxia has direct experience with pharmaceuticals, biologics, and medical devices in all therapeutic areas. The in-depth awareness and understanding of global regulatory and “e” requirements and regulatory strategy that Regxia’s staff possess allows them to minimize the time to market for their clients. Learn more at www.regxia.com
Contact: Cameron McGregor, Manager Business Development – mcgregor@regxia.com (1.416.620.5236 x231)

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