On September 7, the Government of Canada published a
Consultation Paper proposing regulatory changes to a class of
products identified as "self-care products," namely
cosmetics, natural health products and non-prescription drugs. If
implemented, the proposal would combine the separate regulatory
frameworks for these three product classes. 1 The
proposal presents a surprising approach and shift in policy to
Health Canada's current approach of regulating these products
under separate and distinct legislation (i.e., the existing
Cosmetic Regulations, Natural Health Product
Regulations and Food and Drug Regulations).
What You Need To Know
The proposed framework for self-care products would include the
Risk-based approach to self-care products. The
identified risk level (lower, moderate, higher) of a given product
would determine: a) the amount of information Health Canada would
need to review the product; b) the degree of scrutiny before market
entry; and c) the level of monitoring for safety and compliance.
(This is similar to the approach that Health Canada takes for
medical devices.) For lower-risk self-care products, no Health
Canada review or approval would be required prior to market entry;
for higher-risk self-care products, Health Canada would review the
safety of each product and issue approvals prior to market
Health Canada approval of health claims only.
For lower-risk self-care products, claims would not be reviewed;
however, no claims could be made about the diagnosis, treatment,
prevention, or mitigation of a disease or condition. For
higher-risk products, Health Canada would review scientific
evidence to support the claims (such as health claims) being
Compliance monitoring and addressing inconsistences in
post-market powers. Under the proposal, post-market
compliance monitoring activities would vary based on the risk
category of the self-care products. As the potential risk of the
product increases, more oversight would be applied, including
fines, mandatory labelling changes, mandatory product recalls,
The Consultation Paper does not address transition and proposed
dates for implementation, nor does the Consultation Paper set out
sufficient detail to fully assess the impact that the proposed
changes would have on regulated parties. However, as with any
significant regulatory changes, if the proposal were implemented,
regulated parties would likely be impacted in a number of ways that
could include increased costs associated with labelling and
advertising amendments, additional regulatory filings and possible
Health Canada is accepting public comments on the proposed
changes until October 24, 2016. This Consultation Paper represents
a first step toward implementation of the proposed changes and it
is expected that many stakeholders will submit comments on the
Please contact one of the authors if you would like to submit a
comment or would like more information.
On June 30, 2016, the Minister of Justice and Attorney General of Canada, the Minister of Public Safety and Emergency Preparedness, and the Minister of Health announced the creation of a nine-member Task Force on Cannabis Legalization and Regulation (the "Task Force").
Pharma in Brief reported on many legal and regulatory developments of interest to the pharmaceutical industry in 2016. Looking back on 2016 as the new year begins, we have compiled our list of the past year's top headlines below. These include, in no particular order, key developments that affect the pharmaceutical industry and we will continue to monitor in 2017.
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