Health Canada announced it will move forward with Phase III of its prescription drug product transparency initiatives. Beginning October 1, 2018, the Health Products and Food Branch (HPFB) will implement five proposals discussed in its April 2018 “What We Heard” report which relate to Regulatory Decision Summaries (RDSs) and information in the Submissions Under Review (SUR) List. Specifically, HPFB will:
- Post RDSs for final positive decisions (issued on or after October 1, 2018) and final negative decisions (for submissions accepted into review on or after October 1, 2018) for abbreviated new drug submissions (ANDSs) and supplemental abbreviated new drug submissions (SANDSs) that may be of interest to stakeholders, including where HPFB deviates from guidance, for critical dose drugs, and for complex drug substances and/or products;
- Post RDSs for supplemental new drug submissions (SNDSs) for new routes of administration, dosage forms, and strengths (for final positive decisions issued a final positive decision on or after October 1, 2018);
- Add ANDSs to the SUR List (for ANDSs accepted into review on or after October 1, 2018);
- Add the company (sponsor) name to new entries on the SUR List for NDSs and SNDSs (accepted into review on or after October 1, 2018); and
- Add submission class entries to the SUR List (for NDSs and SNDSs accepted into review on or after October 1, 2018).