Preliminary Response: Report 1 - Standards of Evidence for Non-Traditional Natural Health Products

(PDF Version - 329 K)

Natural Health Products Directorate
Health Products and Food Branch

February 15, 2010

Table of Contents

• Preliminary Response
• Appendix A: Report 1 - Standards of Evidence for Non-Traditional Natural Health Products

Preliminary Response

The Natural Health Product Directorate (NHPD) would like to acknowledge the efforts and contributions of the members of the Natural Health Products Program Advisory Committee (NHP-PAC) and its Working Group #1 on Standards of Evidence for Non-traditional Natural Health Products. On January 26, 2010, the NHP-PAC presented its Report 1: Standards of Evidence for Non-Traditional Natural Health Products to Ms. Michelle Boudreau, Director General, NHPD. This report included 33 recommendations (see Appendix A) ensuing from the committee deliberations, including rationales and the range of views/support for each of the recommendations.

The NHPD will complete its review and consideration of the recommendations and prioritize which ones can be implemented throughout 2010-2011 based on available resources. A detailed response for each of the 33 recommendations and action plan will be presented to the NHP-PAC at its next meeting. 

The NHPD agrees that the level of the claim and the risk to the consumer should influence the standard of evidence required to support a natural health product. The NHPD will continue to apply a risk-based approach to the assessment of natural health products licence applications. Drawing from the information provided by the NHP-PAC, the NHPD will determine a method within which the level of a claim and inherent risk of a product could be matched to the type of evidence required such that the assessment could be completed in a timely manner. This would provide clear guidelines and recommendations for applicants and reviewers regarding the type of evidence required to support the safety and efficacy of a product.

The NHP-PAC recommendations focus on several key issues which include but are not limited to the following:

• Improvement of the Information Request Notice and process management
• Development of Pre-Cleared Information
• Multi Medicinal Ingredient products and their combinations
• Levels/type of evidence required to support a Product Licence Application
• Updated guidance documents and communication to stakeholders
• Adverse Reaction Reporting

The range of NHP-PAC recommendations support and in various cases validate the work currently underway at the NHPD through the Process Improvements Project initiatives and reflect other feedback received from stakeholders.

For example, the Information Request Notice process has been greatly improved such that when a reviewer sees that a product licence application could be supported by an NHPD Monograph/NHPD Abbreviated Labelling Standard, the reviewer will counter-propose a claim to the applicant.  The NHPD has also formalized a process whereby Pre-Cleared Information, such as Abbreviated Labelling Standards documents for medicinal ingredients, can be generated to positively affect the product licence applications in the assessment queue. The NHPD has also created a draft application process document to address and discuss a range of proposed performance standards and targets.

A pilot project has also been launched within the NHPD since the January 2010 NHP-PAC meeting with regards to Recommendation #20 to determine the feasibility of creating a separate assessment stream (including Therapeutic Products Directorate monographs) for product licence applications where all the medicinal ingredients attest to NHPD Pre-Cleared Information (Monographs and/or Abbreviated Labelling Standards). It is anticipated that the results of this pilot will be available for the March 2010 NHP-PAC meeting.

The NHPD acknowledges the challenges faced by applicants and reviewers in determining the standards of evidence required to support multi-medicinal ingredient products in the non-traditional stream.  The NHPD is committed to developing and providing applicants and reviewers with appropriate guidelines and frameworks to clarify the types and amount of evidence required to support a claim in consideration of the NHP-PAC recommendations.

In addition, the NHPD will continue to provide applicants with timely information on new and updated Pre-Cleared Information, guidelines on safety, efficacy and quality of finished natural health products and other requirements, as it becomes available, through its Bureau of Product Review and Assessment (BPRA) e-mail list.  In addition to this advance information practice, the NHPD will also focus on developing and updating guidance documents for the Health Canada website.  The NHPD is committed to helping natural health products licence applicants understand the requirements to support a product licence application, and will continue to offer workshops and provide information on natural health products to stakeholders.

NHP-PAC recommendations related to adverse reaction reporting and compliance and enforcement will be brought forward to other Natural Health Products Program directorates for response (i.e., the Marketed Health Product Directorate and the Health Product Food Branch Inspectorate respectively), through existing Program committees and working groups.

An initial response to each of the 33 recommendations will be presented to the NHP-PAC at its March 2010 meeting.