Regxia Inc. recently had the opportunity to exhibit and attend the CAPRA 2024 Pharmaceutical Symposium held in Toronto, Canada.
The symposium is a one-day event that provides CAPRA members an opportunity to hear from both industry leaders and Health Canada professionals alike. This joint platform allows for all parties to gain and share new regulatory insights through in-person panel discussions.
Some key insights offered by Health Canada and industry leaders are described below:
Negative Decisions Issued by the BPS
Industry members have long cited the increasing trend of negative decisions issued by the Bureau of Pharmaceutical Sciences (BPS) for drug product submissions, which often seem to occur at the tail-end of Health Canada’s allotted review timeline.Â
Health Canada analyzed three fiscal cycles to better understand and assess if the industry’s concern on rising negative decisions was warranted. Findings indicated that negative decisions issued for the innovative sector had decreased over time while negative decisions issued for generic submissions had increased 10-15%.
Further analysis on the deficiencies/categories which resulted in negative decisions indicated that a rising increase in nitrosamine issues, biowavers not granted, stability study concerns, container closure system issues, and master file related major objections were some major causes.
Health Canada understands that negative decisions are costly for the industry and has reiterated their common goal to improve the positive decision rate in the first cycle of drug submission reviews.
The presentation by Health Canada offered industry members an  awareness of the major problem areas which resulted in negative decisions issued by the BPS. Ultimately, high quality submissions from the industry are essential to facilitate the timely review of drug submissions and understanding problem areas and undertaking measures to prevent concerns in future submissions should be the goal for industry leaders.
Nitrosamine Updates
An ICH addendum (M7) on nitrosamine impurities is currently under preparation to drive international harmonization of nitrosamine management
An expert working group with 40+ personnel has been formed, with Alisa Vespa (Senior Scientific Evaluator/Nitrosamine Safety Subject Matter Expert, Office of Risk Management Division, Health Canada) as the Regulatory Chair
A concept paper outlining scope of topics for the addendum is anticipated to be finalized soon
Industry leaders have expressed their recommendation for Health Canada to blend the best of the FDA’s & EMA’s approach to nitrosamine impurities to help improve international alignment while ICH M7 is prepared.
Contact us, if you missed the symposium and wanted an opportunity to gain additional insights on Health Canada’s regulatory pathways and strategies for handling the evolving regulatory hurdle for nitrosamine impurities.