The next six months for Canada’s Natural & Nonprescription Health Products Directorate (NNHPD) will be extremely busy according to its recently announced plans. With more than a dozen priorities on its list, it remains to be seen if all these activities will be completed before the end of March 2018. However, slippage is not uncommon with government agendas and only time will tell.
Topping the list is the ongoing Self-Care Framework consultation. While the original proposals from four years ago were intended to determine how OTC medication regulations could be updated to distinguish them from prescription drug requirements, the government shifted gears over the past year to include other products in the review (Natural Health Products, cosmetics and fragrances). The consultations have resulted in some of the most commented-upon proposals in Health Canada’s history and NNHPD says that they will be focused upon examining the inputs and preparing for next steps through the winter months.
Green tea among the planned monographs
Other issues that the NNHPD is examining include Plain Language Labelling (PLL) for OTC products, dosage forms for children and updating the OTC monograph system. Monographs that can be used to gain early access to the market continue to be a tool that government wishes to improve upon. The following monographs are scheduled to be posted between November and March 2018:
- Green tea extracts
- Multivitamin / mineral supplements
- Selenium
- Chlorella
- Kelp products
- Bromelain, stem & fruit
- Joint health products, multiple ingredient
- Serrapeptase
In addition, activities planned by the NNHPD include developing distinct regulations for disinfectants, updating the online databases, increasing their compliance programme for Natural Health Products, revisions to the product application process and management policy (by April 2018), renewing the website and publishing adverse event signal assessments (most recently done for green tea extract and liver injury).
For a more in-depth analysis of Canada’s upcoming OTC regulatory changes, be sure to subscribe to OTC INSIGHT North America. Enquire today by emailing owen.hartnett@nicholashall.com
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