From the beginning of next year, Health Canada will only accept submissions for certain regulatory procedures in the electronic common technical document (eCTD) format. As of that date, Health Canada says that sponsors must use eCTD format for all new drug submissions (NDS) and abbreviated new drug submissions (ANDS), as well as supplements to both submission types. On 24th of April 2017, Health Canada officially confirmed the deadline for eCTD submissions - to read the official announcement from Health Canada, click here.
As of January 1st, 2018, the following regulatory activity types, as well as all additional information and subsequent regulatory activities/transactions (as per section 1.3 of the Guidance Document Preparation of Drug Regulatory Activities in eCTD Format) for human drugs, must be filed in eCTD format:
- New Drug Submission (NDS);
- Supplement to a New Drug Submission (SNDS);
- Abbreviated New Drug Submission (ANDS); and
- Supplement to an Abbreviated New Drug Submission (SANDS).
Regulatory activities for the following are recommended, however, not mandatory for filing in eCTD format:
- Master Files;
- Clinical Trial Applications (eCTD CTA pilot only);
- Drug Identification Number (DIN) Applications and Post-Authorization Division 1 Changes (PDC) for Human drugs.
Regulatory activities for the following currently remain out of scope for filing in eCTD format; they must be filed in “non-eCTD electronic-only”:
- Medical Devices;
- Veterinary Drugs.
The agency also notes that sponsors can request an exemption on case-by-case basis, but it expects companies to provide a rationale for the exemption as well as an intended plan for converting to eCTD format. For many sponsors, this should not be a dramatic transition - according to Health Canada data, as of December 2016, 84% percent of regulatory activities for drugs are filed in eCTD format as of December 2016.
Additionally, as previously announced, Health Canada says sponsors will be required to file all electronic submissions under 10GB via the Common Electronic Submissions Gateway (CESG), while submissions over the 10GB file size limit must be submitted on physical media.
For further help and advice on converting your submissions into eCTD format, contact EXTEDO and our team of regulatory experts will be happy to provide further guidance.