Natural and Non-prescription Health Products Directorate Upcoming activities: Aug to Dec 2017

1. Consulting Canadians on the Regulation of Self-Care Products in Canada

Consultation sessions were conducted in-person and by webinar across Canada in April, May and June 2017 to engage consumers and other stakeholders on the development of a modernized approach to regulating self-care products. Summaries of what we heard during these consultations.

Canadians are invited to continue to share their views on a proposed framework for the regulation of self-care products by sending their comments to the following email address: selfcareproducts-produitsautosoins@hc-sc.gc.ca. The NNHPD is committed to taking all comments and concerns into consideration. We will review and consider all feedback received as the policy proposal is finalized.

Stay tuned to the self-care website for updates as they become available.

2. Reclassification of Certain Natural Health Products (NHPs) as Food

The NNHPD and Food Directorate (FD) have identified a number of licensed products at the Food-NHP interface which best fit the definition of a food, in accordance with pre-existing classification criteria. Health Canada will be contacting these Natural Product Number (NPN) holders directly in the near future to transition their products to foods.

3. Disinfectants/Sterilants/Sanitizers/Cleaners

The NNHPD is working collaboratively with the Pest Management Regulatory Agency (PMRA) and the Healthy Environments and Consumer Safety Branch (HECSB) to examine the oversight for disinfectants, and post-implementation of the proposed framework for self-care products. In the short-term, the NNHPD and the PMRA have explored possible efficiencies in the pre-market review for dual-registration products and will provide an update at the next multilateral stakeholder session.

4. Monograph Publication

The NNHPD is examining its strategic approaches to monograph development. This includes considerations for the finalization of monographs currently in draft form, updates to existing monographs that improve clarity and comprehension, and development of new monographs to further support licensing efficiencies.

Stakeholders will continue to be consulted on newly published and anticipated revisions to existing monographs, as identified within the Calendar of Activities. However, unanticipated revisions, such as those identified through various pharmacovigilance activities, will continue to be published without consultation.

The following monographs are scheduled to be posted between August and December 2017.

• Multi-Vitamin/Mineral Supplements
• Antioxidant
• Cognitive function products
• Green Tea Extracts
• Selenium
• Chlorella
• Devil's Claw
• Bromelain, Stem
• Bromelain, Fruit
• Joint Health Products, Multiple Ingredient

Additionally, the "statement to the effect of" is being removed as NHP monographs are being updated in order to advance system developments and address attestation failures.

5. Bilateral and Multilateral Meetings

NNHPD is scheduling bilateral meetings with associations in the fall for those who have expressed an interest as well as a Fall Multilateral Meeting.

6. Plain Language Labelling (PLL)

A teleconference call is planned for Fall 2017 to provide clarity and answer questions related to the implementation of PLL.

7. Chemicals Management Plan (CMP)

The CMP assesses environmental and human health risks posed by chemical substances, and develops and implements measures to prevent or manage those risks. Some substances that are assessed under the CMP are ingredients (medicinal or non-medicinal) in natural and non-prescription health products.

Draft screening assessments are published for a 60-day public comment period in the Canada Gazette. Information on how to submit comments will accompany the draft screening assessments. If you would like to be notified when draft screening assessments are published, you can subscribe to receive the latest news on the Government of Canada's chemical substances website.

8. Compliance Monitoring Projects

The Regulatory Operations and Regions Branch (RORB), in response to the evaluation of the Natural Health Products Program, implemented a pro-active compliance monitoring project that pilots on-site inspection of Good Manufacturing Practices (GMP) compliance for manufacturers and importers of natural health products. Follow-up based on the findings of the site visits is ongoing. Information on the project will be posted online later this year.

9. Additional Directions of Use for Children's Dosage Forms

Natural health products with solid dosage forms, such as tablets and capsules, may not be suitable for children less than 6 years of age if the product label does not provide specific instructions of use. Between May 2017 and April 2018, NNHPD will determine whether licensed products have appropriate dosage forms for children and will request specific instructions for use in children to be added to the label of already licensed products. Additionally product monographs have been updated to include guidance on appropriate dosage forms for children.

10. Natural Health Product Reconsideration Process

The NNHPD is working closely with the Food and Drugs Act Liaison Office (FDALO) to optimize the reconsideration process of refused natural health product (NHP) license applications and to harmonize this process with its human drug model where appropriate. Work is underway on drafting a revised reconsideration process which is expected to be consulted on in the Fall of 2017.

11. Application Management Policy (AMP)

• NNHPD is launching an update to the proposed for the Application Management Policy (AMP) for natural health products. This update will provide greater clarity on internal processes and requirements within the Natural and Non-prescription Health Products Directorate (NNHPD). It will contribute to:
• Improved quality of applications for all classes;
• Improved processes efficiencies, setting realistic timelines, while ensuring regulatory obligations are being met and;
• Ensuring the AMP accurately reflects current policy and aligns with the modernized IT system.

12. Updates to the Natural Health Products Online

The NNHPD is updating and enhancing its Natural Health Products Online System to release improved web enabled application forms. In late 2017, NNHPD will be releasing a new application form to be used specifically for Amendments and Notifications. This form will help streamline the input of required information (applicants provide only the required Amendment/Notification information), application intake, and enable automated processing of Amendments and Notifications. The new form will also remove the dependency on previous application forms. The input from engagement sessions with key stakeholders will be used to guide development and testing, ensuring that the new form adds value and meet the needs of end users while also satisfying the program's regulatory requirements. We would like to thank all stakeholders who attended the electronic application form co-design session on July 13, 2017 and took the time to provide us with valuable feedback and suggestions. We look forward to continued collaboration.