Health Canada has updated the timeline for Mandatory Use of eCTD Format for Types of Regulatory Activity.
From since 2004, Health Canada is accepting regulatory activities in eCTD format. As of December 2018, 93 percent of regulatory activities (Part C, Division 8 of the Food and Drug Regulations, for human drugs) have been submitted in eCTD format.
- Regulatory Activity Types Required in Mandatory eCTD Format;
|Date||Regulatory Activity Types Required in Mandatory eCTD Format|
|January 1, 2018||Division 8 (for Human Drugs only)
|June 1, 2019||Remainder of Division 8 (for Human Drugs only)
|June 1, 2019||Post-market Vigilance Data (Human Drugs only)
|September 1, 2019
(to be confirmed)
- Regulatory Activity Types Not Mandatory in eCTD Format but Recommended;
- Clinical Trial Applications (eCTD CTA pilot only),
- UDRA: Notification of Discontinued Sale (DIN cancellation) and Notification of interruption of sale
- Non-Prescription Human Drugs* regulated under Division 1 of the Food and Drug Regulations (i.e., DINA (over the counter products only), DIND, DINF, PDC and, Post DIN Notifications)
- Regulatory Activity Types Not Required in eCTD Format – Exemption (must be filed in “non-eCTD electronic-only” format)
- Medical Devices
- Veterinary Drugs
Team Masuu has qualified and experienced Regulatory Operations professionals who provide end to end eCTD publishing support and services throughout the life-cycle of product
For more details please reach us at firstname.lastname@example.org.