Health Canada recently announced that it will move forward with Phase III of its prescription drug product transparency initiatives. As of 1 October 2018, the Health Products and Food Branch (HPFB) will implement five proposals discussed in its April 2018 What We Heard report concerning regulatory decision summaries and information in the Submissions Under Review (SUR) List.
Specifically, the HPFB will:
- post regulatory decision summaries for final positive decisions (issued on or after 1 October 2018) and final negative decisions (for submissions accepted for review on or after 1 October 2018) for abbreviated new drug submissions (ANDS) and supplemental abbreviated new drug submissions (SANDS) that may be of interest to stakeholders (including where the HPFB deviates from guidance) for critical dose drugs and complex drug substances and products;
- post regulatory decision summaries for supplemental new drug submissions for new routes of administration, dosage forms and strengths (for final positive decisions issued on or after 1 October 2018);
- add ANDS to the SUR List (for ANDS accepted into review on or after 1 October 2018);
- add the company (sponsor) name to new entries on the SUR List for new drug submissions and supplemental new drug submissions (accepted into review on or after 1 October 2018); and
- add submission class entries to the SUR List (for new drug submissions and supplemental new drug submissions accepted into review on or after 1 October 2018).
For further information on this topic please contact Abigail Smith at Smart & Biggar/Fetherstonhaugh by telephone (+1 416 593 5514) or email (email@example.com). The Smart & Biggar website can be accessed at www.smart-biggar.ca.
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