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As of December 3, 2012, 91% of the product licensing application backlog was complete. 900 Pre-Natural Health Products (Unprocessed Product Licence Applications) Regulations (UPLAR) backlog applications are left. The NHPD remains on target to complete the backlog by the UPLAR deadline of February 2013. Batches of products remaining include weight maintenance, enzymes, and detoxification.
Since 2011, the NHPD has implemented a number of process improvements, resulting in a significant increase in the number of product licence applications being approved. The licensing rate has increased from 61% licensed in the second Quarter of 2011-12 to 82% licensed in the second Quarter of 2012-13. Initiatives have focused on batching of pre-UPLAR applications, identifying pathways for licensing for many applications as well as the publishing of an increased amount of pre-cleared information, representing hundreds of ingredients.

CAND emphasized the importance of effective and timely communication on issues impacting naturopathic doctors (NDs). The NHPD concurred and it was agreed that the Director General of NHPD and CAND Executive Director would resume monthly teleconference meetings.

On August 1, 2012 and October 5, 2012, Health Canada sent out notices outlining the first two phases of a pilot plan to streamline clinical trial application review activities within the NHPD. As outlined in these notices, all Clinical Trial Applications (CTAs) which contain claims not appropriate for self-care use have been transitioned to the Therapeutic Products Directorate (TPD) or the Biologics and Genetic Therapies Directorate (BGTD).
On November 27, 2012, the NHPD began the transition of adverse reaction (AR) reporting for all natural health products (NHP) clinical trials (CT) to TPD or BGTD. This third phase applies to all ARs for all NHP CTs, not only those containing NHPs which are not appropriate for a self-care context. The public notices of August 1, October 5, and November 27 were sent to every stakeholder identified as a contact in submissions to NHPD for clinical trial authorizations, including naturopathic doctors.
The NHPD is currently developing tools to ensure all internal information at NHPD on clinical trials is accessible to staff in TPD and BGTD. The goal is to minimize the impact of this transition on review and AR reporting activities.

CAND indicated that while NDs are primary care providers, qualified in the use of natural therapies, they don't have access to a range of products that are placed on restricted schedules. The NHPD and CAND acknowledged the challenges in dealing with access and prescribing rights given that the practice of naturopathic medicine is regulated by the provinces. The NHPD and CAND had a discussion on how to address the issue in this context. The discussion was intended to be the beginning of a dialogue, to be continued at future bilateral meetings.
The NHPD also noted the key role NDs can play within the context of clinical trials (CT). NDs can take on the role of principal investigator or co-investigator. The principal investigator is the team leader for the entire CT, responsible for coordination of the clinical research, including data collection and analysis. The co-investigator is a member of the clinical trial team, contributing expertise relevant to the CT. In both cases, a licensed physician must be associated to the CT, taking on the role of qualified investigator, the term "qualified" having a very specific meaning set out in the Food and Drug Regulations and the NHP Regulations.

CAND enquired on the role it can play in informing decisions made by Health Canada regarding natural substances. The NHPD highlighted that all guidance and pre-cleared information is posted for consultation and that CAND members' feedback is valued. There was also discussion about Health Canada's response to stakeholder comments provided during Canada Gazette consultation periods. NHPD agreed to provide CAND's feedback on this process to relevant others in the Health Products and Food Branch.

Ms. Dina Aly, Acting Senior Advisor and Issues Management, Director General's Office, Natural Health Products Directorate (NHPD)
Ms. Diane Beauregard, Senior Program Officer, Stakeholder Engagement and Outreach, Bureau of Policy and Risk Management (BPRM), NHPD
Dr. Kevin Bernardo, Scientific Evaluator, Marketed Biologicals, Biotechnology and Natural Health Products Bureau, Marketed Health Products Directorate (MHPD)
Dr. Leo Bouthillier, Manager, Clinical Trials Group 2, Office of Clinical Trials, Therapeutic Products Directorate (TPD)
Mr. Matthew Bown, Senior Policy Advisor, BPRM, NHPD
Dr. David Cunningham, Medical Evaluator, Marketed Biologicals, Biotechnology and Natural Health Products Bureau, MHPD
Ms. Stephanie De Silva, Acting Manager, Submissions Management Division, Bureau of Product Review and Assessment (BPRA), NHPD
Dr. Hoda Eid, Manager, Adverse Drug Reaction Unit, Office of Clinical Trials, TPD
Mr. Adam Gibson, Acting Director General, NHPD
Ms. Christine Gillis, Acting Director, BPRM, NHPD
Ms. Dhurata Ikonomi, Manager, Stakeholder Engagement and Outreach, BPRM, NHPD
Dr. Robin Marles, Senior Science Advisor, BPRM, NHPD
Ms. Sara O'Connor, Acting Director, BPRA, NHPD
Dr. Tanya Ramsamy, Acting Manager, Clinical Trials Group 1, Office of Clinical Trials, TPD
Mr. Joel Raymond, Manager, Submission Management Division, Office of Clinical Trials, TPD