2 min read
With the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach. With that said, the next market they should focus for their data submissions is Health Canada. The health authority of Canadian landscape, Health Canada (HC) has revised the existing submission requirements recently and mandated that they should be in electronic format for certain filings post January 1st, 2018. Beginning the first day of 2018, Health Canada will accept submissions in electronic common technical document (eCTD) format for certain regulatory filings. Types of Regulatory filings to be submitted in eCTD format only
- New Drug Submissions (NDSs)
- Supplemental NDSs (SNDs)
- Abbreviated NDSs (ANDSs)
- Supplements to ANDSs (SANDSs)
- All lifecycle submissions pertaining to the above
The transition and the chances of being exempted: With the major stake of regulatory activities are already being filed in eCTD format, the mandatory deadline seems may not be considered as a sudden one to get adopted to. Even if it poses challenges for transition, it should be noted that Health Canada may allow sponsors an exemption from the aforesaid requirements for individual products, provided companies cite a valid reasoning. However, a clearly chalked out plan for converting to eCTD format should be submitted soon via email and the same will be considered on case-by-case. eCTD format recommended but not mandatory for: Not all regulatory documents and activities would require mandatory eCTD submissions beginning January 1, 2018, but Health Canada says it recommends that sponsors begin using eCTD format to enable a smooth transition in the future. The submission types for which, eCTD format is not mandatory are as follows:
- Master files
- Clinical trial applications (CTA)
- Drug identification number (DIN) applications and
- Post-authorization division 1 changes (PDC) for human drugs
eCTD format remains out of scope for: Another crucial point to note is that medical device and veterinary drug submissions "remain out of scope for filing in eCTD format" and must be in "non-eCTD electronic-only" format only. With all said and done, manufacturers focusing on Health Canada electronic submissions must realize that they should be prepared way before to avoid any last-minute hiccups. Right from investing in requisite infrastructure, resources and training programs, the entire process can turn out to be quite exhaustive. In such a scenario, the need of the hour is a regulatory industry expert with both expertise and experience in handling various regulatory and e-publishing needs, who has an in-house e-publishing software and expert publishing submission personnel to effectively navigate the unique needs in a timely fashion.
