Summary of the Nitrosamines Stakeholder Webinar - Feb 10, 2021

The webinar was held on February 10, 2021 from 8:30 -12 pm EST. Almost 700 stakeholders from across the world attended, along with several regulators from the Nitrosamine International Strategic Group, and Health Canada reviewers, managers, inspectors and regulatory staff connected to work on nitrosamine impurities. A brief summary of events is provided below.

The chair of the Nitrosamines Stakeholder webinar, Anik Michelle Chartrand, welcomed attendees and introduced Dr. John Patrick Stewart, Director General of the Therapeutic Products Directorate, who provided the opening remarks. Dr. Stewart emphasized the importance of the Nitrosamines work and outlined the objectives of the session - sharing ongoing and proposed activities and getting industry feedback.

A Health Canada presentation followed with contextual overview by Gary Condran. Dr. Stephen Horne discussed potential root causes and considerations for API and Drug Product Pharmaceutical development. Dr. Corinne Bensimon presented the nitrosamine risk in biologics and radiopharmaceuticals and Dr. Stéphanie Para talked about the expectations for nitrosamine data in new drug submissions and certain supplements. Christine Taillon presented an update on the compliance and enforcement approach followed by a recap of key updates to the December 15, 2020 Nitrosamines Questions and Answers guidance by Gary, Steve and Dr. Alisa Vespa to round out the Health Canada presentation.

Select industry associations gave invited presentations. Speakers representing Innovative Medicines Canada, the Canadian Generic Pharmaceutical Association, Food, Health and Consumer Products, and the Cosmetic Alliance Canada gave short talks on their nitrosamine work with Health Canada, particularly the challenges and concerns facing them.

Following the presentations, a Health Canada panel answered stakeholder questions submitted throughout the session, as well as pre-submitted questions from industry associations. Over 50 different questions were received on a variety of emerging issues concerning nitrosamines. The panel was able to answer almost 40 questions during the time allotted and any remaining questions from stakeholders were directed to the BPS inquiries generic email, to ensure the quickest response.

Linsey Hollett, Director General of the Health Product Compliance Directorate, provided closing remarks highlighting the importance of dialogue and transparency with industry in working together to assess and mitigate the risk of presence of nitrosamines impurities in human drug product and to control and minimize their presence. Linsey thanked the industry presenters and participants for their valuable input. The questions and feedback received will be used to support ongoing nitrosamine work, shape future activities and inform additional guidance to the industry.

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