In an announcement made April 24, 2017 Health Canada reaffirmed its intent to transition all regulatory submissions over to eCTD format.
Starting January 1, 2018 all New Drug Submissions (NDSs), Supplemental NDSs (SNDSs), Abbreviated NDSs (ANDSs), and Supplements to ANDSs (SANDSs) and their lifecycle submissions will be required to be submitted in eCTD format through the common electronic gateway.
While not all regulatory activities will require mandatory eCTD filing, the following activites are recommended to be filed in eCTD through the gateway:
- “Master Files
- Clinical Trial Applications (eCTD CTA pilot only)
- Drug Identification Number (DIN) Applications and Post-Authorization Division 1 Changes (PDC) for Human drugs”
Similarly, Medical Devices and Vetrinary Drug applications “currently remain out of scope for filing in eCTD format; they must be filed in “non-eCTD electronic-only”” format.
This implementation date was first announced in July of 2016 to provide industry enough notice to begin preparing for the transition to electronic published submissions. Health Canada is aware of the potential increased financial burden that adopting an e-publishing platform can place on industry and as such advises any company requiring an exemption from the mandatory eCTD format requirements to submit an individual product exemption by email. Exemption requests “will be considered on a case by case basis.” Directions on what to include and where to submit these requests can be found in the Health Canada announcement – http://www.hc-sc.gc.ca/dhp-mps/prodpharma/activit/announce-annonce/ectd-mandatory-notice-avis-obligatoire-eng.php .
Fortunately however, there are alternatives to investing in the infrastructure and training required to onboard the appropriate e-publishing services. Regxia Inc. has been using its chosen e-publishing software for the past 10 years and we are happy to say that Health Canada has also adopted the same system. Since first offering this service, Regxia has compiled, validated and submitted over 5000 e-submissions (base submissions and lifecycle sequences) to Health Canada and the US FDA. The recent migration of both agencies to the same e-software allows the reviewers to be capable and comfortable navigating our client’s submissions during review.
Regxia’s expertise in compiling both clinical and marketing applications in tandem with our e-publishing services positions us as a key outsourced assets for companies of any size who require support in meeting the FDA’s e-requirements.
We look forward to assisting more potential clients with their Regulatory and e-Publication needs.
The Health Canada Announcement can be found here:
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 – firstname.lastname@example.org