Regulations/Path to Market

Regulations/Path to Market2019-01-11T13:38:20+00:00

Regulatory Pathway

Health Canada recently released “Proposed Regulations Amending the Cannabis Regulations (new classes of cannabis) and Proposed Order Amending Schedules 3 and 4 to the Cannabis Act”.  These proposed changes introduce three new classes of cannabis products: edibles, concentrates and topicals.  The introduction of these new classes may present an opportunity for the Company to bring combination products to the market as an adult-use edible cannabis product.  It is proposed that only approved food ingredients and additives will be permitted for use in this class of products – which will require the Company’s additives to qualify under such rules and which may also be influenced by the delivery mechanism for our formulations.  Although health claims are not permitted on this type of product, this commercialization option represents the fastest route to market and allows for distribution through both healthcare practitioner-facilitated medical-use channels and recreational channels.   Accordingly, our intention is to explore the use of these channels

Currently the only commercialization option that will allow for making health claims and the distribution of literature to healthcare practitioners is as a prescription cannabis drug requiring a Drug Identification Number (DIN).  This route requires evidence from human clinical trials that demonstrates the safety and efficacy of the products to allow for premarket authorization by Health Canada.  Two cannabis drug products have received Health Canada authorization thus far.  To commence a clinical trial program, we will collaborate with experienced partners who are able to obtain the No Objection Letter for the conduct of these studies and the Cannabis Research License required by Health Canada.  Building a portfolio of clinical research data on our products will require time; however, has the benefit of gaining broader market acceptance and possibly inclusion on drug formularies approved by insurance providers.

Finally, Health Canada has indicated that further research is required before they will consider authorizing the inclusion of cannabis in self-care products (natural health products, over-the-counter drugs).  Health Canada has also published proposed changes to the regulatory framework of self-care products with a plan to issue targeted changes to the Food and Drug Act in early 2019 for public consultation.  Although these regulatory changes may not have a direct impact on the oversight of cannabis products at this time, they may also open the possibility of an expedited regulatory pathway for our formulations should an additional category for cannabis self-care products be added in time.  Self-care products also require substantiating evidence for efficacy and safety derived from human clinical trials.  In commencing a clinical trial program, the Company will be poised to capitalize on any changes that will facilitate the self-care market by already obtaining data to support health claims.