By Robert Labriola
We’ve seen recent trends and activity with regards to pharmaceutical regulatory submissions to Health Canada. Several questions and queries have come into our regulatory operations department, and the following information will address a few popular topics.
Health Canada implements eCTD for Clinical Trial Applications
Health Canada accepts electronic Common Technical Document (eCTD) submissions for pre-clinical trial application consultation meetings, clinical trial applications (CTA), amendments, notifications, and responses for post-clearance data related to those applications. CTA submissions via eCTD is significant step in the propagation of eCTD. The adoption of eCTD for CTAs spawned from a successful pilot the health authority conducted.
As with a traditional submission, Health Canada reviews the package and issues a no-objection letter (NOL) before a sponsor initiates a trial or an amendment to a trial. And the same process is applicable, pharmaceuticals go to the Therapeutic Products Directorate and biologics to the Biologic and Radiopharmaceutical Directorate.
At Synchrogenix, Certara’s regulatory science division, we leverage a dynamic electronic tracker to track of all the components in the CTA. Regulatory Operations gathers and publishes the components for CTA submissions in eCTD format. The draft of the submission can be viewed with an eCTD viewing tool or our WebReview tool.
Once a sponsor files in eCTD format, all subsequent transactions for the same submission must also be in eCTD format. If this is your first eCTD submission to Health Canada, you must first submit a sample transaction. The agency also recommends holding a pre-technical meeting before making your first live submission. Upon completion of a test, request a dossier identifier for your live application.
Regulatory submissions under 10 gigabytes must be electronically transmitted via the Common Electronic Submissions Gateway (CESG). The CESG is where submissions are uploaded and reviewed by the authority, which is much faster compared to the days of mailing in a CD-ROM or other media. The CESG is synonymous with the FDA’s Electronic Submission Gateway (ESG), and it leverages the same gateway technology. You select Health Canada or “HC” as the center where you are transmitting the submission.
Module 1 and validation were updated to reflect the changes. We suggest you check validation reports carefully and make any necessary adjustments.
You can refer to the Health Canada Filing Submissions Electronically page where the following information is available:
- Life Cycle Management at the Document Layer for eCTD Clinical Trial Regulatory Activities
- Clinical Trial Applications (CTA) in eCTD format
- Table of Clinical Trial Regulatory Transaction (sequence) Descriptions
There are a few activities that are “out-of-scope” for filing in eCTD format, such as submitting clinical trial site information, development safety update reports (DSURs), signal assessment related requests or fax-backs for the Biologics and Genetic Therapies Directorate.
As a side note, there is an interim order for clinical trials for drugs and devices relating to COVID-19. For a clinical trial application for COVID-19, you must indicate if you are filing the application under this new pathway:
- Both in the cover letter and
- on the Canadian 3011 form
Please see Health Canada’s website for details including information and instructions on filing electronically. Their website also provides additional information on Health Canada and eCTD, including the option to submit CTAs via eCTD.
Submitting Master File transactions via the Common Electronic Submissions Gateway (CESG)
Starting January 1, 2020, all regulatory transactions for Master Files prepared in the non-eCTD format must be sent via the Common Electronic Submission Gateway (CESG). We have seen a spike in these types of submissions. The CESG has been in operation at Health Canada since February 2014, and it provides a secure and prompt way to transmit submissions to the agency.
Previously, it was permissible to send Master File transactions on physical media, such as compact disc, DVD, or USB. Starting January 2020, this is no longer possible, unless the contents and files are greater than 10 GB in size. Instead, you must now arrange the files electronically and transmit them via the CESG.
If you need to submit clinical trial applications and related submissions using eCTD format to Health Canada, we can help. Our Regulatory Operations team and eCTD submission software are experts in eCTD submission and CESG transmission to Health Canada. Our customized solutions and ultra-rapid submission support leveraged by technology and flexible, highly qualified professionals can help you achieve accelerated regulatory submission success. We have global offices, including Montreal, Canada.
To learn more, please contact us.