From 01 January 2020, Health Canada will only accept new Drug Master File (DMF) applications submitted in electronic Common Technical Document (eCTD) format. DMFs are submitted to Health Canada to prove the quality, safety and efficacy of medicinal products. The move to the eCTD format enables a common submission intake process as well as standardization and improved business processes.
Health Canada has already accepted eCTD formatted submissions since 2004. According to the authority, as of December 2018, 93% of regulatory activities under Part C, Division 8, for human drugs, have already been filed in eCTD format. Whereas New Drug Submissions (NDS), Supplement to a New Drug Submission (SNDS), Abbreviated New Drug Submissions (ANDS), and Supplements to an Abbreviated New Drug Submission (SANDS) have had to be submitted in eCTD format since 01 January 2018, DMF applications were not previously mandatory to comply with the eCTD requirements. The move towards eCTD compliant DMFs enables Health Canada to further align their regulatory requirements with other authorities worldwide.
As of 01 January 2020, the following DMF types must be submitted in eCTD format or they will be rejected:
- New Type I Master Files – Drug Substance
- New Type II Master Files – Container Closure Systems and Components
- New Type III Master Files – Excipients
- New Type IV Master Files – Drug Products
Regarding existing non-eCTD electronic Master Files, the authority recommends the conversion to eCTD although, the conversion is not mandatory. A request for exemption is not required if Master File holders are unable to convert their existing DMFs.
The conversion from paper to eCTD presents significant challenges for many DMF holders. Staying compliant will require additional effort from companies with paper DMFs already organized in the CTD format.
If you want to convert your existing non-eCTD DMFs to the eCTD format, you need to ensure that:
- appropriate level of granularity is used in eCTD submission documents
- document content is optimized for eCTD submission
- documents conform to PDF specifications
If your organization requires any help converting your DMFs to eCTD format, contact us now. EXTEDO´s team of regulatory experts is here to support you throughout your journey by providing you with a wide range eCTD services.
If you are further interested why eCTD is not only a burden but can bring a lot of benefits and opportunities for your company, then just download the eCTD white paper.