Significant progress was made during our spring Regulatory Workshop on advancing the approval of active ingredients already long approved in the European Union and other trusted jurisdictions but not approved for use in Canada due to Health Canada requirements that they be assessed under its “new drug” approval process. This process – designed and intended for prescription pharmaceuticals – is not appropriate or cost effective for low risk cosmetic like-drugs such as sunscreens, toothpastes, mouthwashes, anti-dandruff shampoos, antiperspirants, antiseptics, anti-acne and other medicated skin care products As such, applications take over 300 days to review, have a $600,000 plus fee attached, and require a new application for each product as well as the use of two or more already approved ingredients.
Cosmetics Alliance, along with the support of our colleagues at Cosmetics Europe through the Canada-E.U. Trade Agreement (CETA), have been pursuing a more appropriate regulatory process for approving these low risk cosmetic-like products and have made raised them in the context of the Carney government’s Red-Tape Reduction initiative.
Although Health Canada did not intend to pursue relief for these products in their initial red-tape reduction plan, advocacy efforts by Cosmetics Alliance and having the matter raised as a trade barrier by the European Union, moved Health Canada officials to initially propose the use of a Ministerial Order (exemption) for secondary sunscreens only. As confirmed by NNHPD Director-General Stephen Norman at the Reg Workshop, this has now been extended to ALL applicable sunscreen actives. After hearing further from our members, and after a conversation with CA President Darren Praznik, they are now prepared to consider actives for additional cosmetic-like drugs.
In a follow-up call with CA, NNHPD has asked that we provide a list of such active ingredients, where they have already been approved, and in what product categories they are used. This will be used to inform the policy proposal for a Ministerial Order which NNHPD will be discussing with the leadership of Health Canada.
Given the short time frames under which NNHPD is operating, CA has reached out to member companies, is preparing the necessary materials, and will be forwarding them shortly to NNHPD.
CA also will be continuing its advocacy efforts with senior officials to secure support for this important measure.
If approved, it will allow for a greater array of sunscreen and other cosmetic-like drug products to be sold in Canada either through importation or manufacture in Canadian facilities.
Stay tuned as CA will report as this issue progresses.
