CA participated in the Natural and Non-prescription Health Products Directorate (NNHPD) Multi-Association Meeting held virtually on January 29 during which NNHPD’s new Director-General, Natalie Page, was formally introduced. The primary objective of the meeting was to review highlights of Health Canada’s Forward Regulatory Plan 2020-2022.
The Forward Regulatory Plan provides information on regulatory initiatives that Health Canada aims to propose or finalize in the next 2 years through pre-publication in the Canada Gazette, Part I and final publication in the Canada Gazette, Part II. The Plan also includes regulatory initiatives that are planned to come forward over a longer time frame.
CA is happy to report that the Forward Regulatory Plan clearly establishes HC’s post Covid-19 commitment to the Self-Care Framework as a priority. The Self-Care Framework will roll out in phases as follows:
• Phase I – Targeting spring 2021: Introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve labelling of natural health products (NHPs). This proposal will require essential risk information to be presented in a standardized format, with minimum font size and black-on-white contrast, making it easier to read, understand and compare with that for other similar self-care products, such as non-prescription drugs, on store shelves. The use of plain language will also ensure that information on labels can be easily understood by Canadians. (These changes are necessary to eventually align labelling requirements for all cosmetic, natural health and drug products regulated together in each self-care risk category)
• Phase II – Targeting spring 2022: Targeted amendments to introduce for consultation a risk-based approach to regulatory oversight for non-prescription drugs. These include: expedited pathways for lower-risk products. These changes are intended to align the oversight for non-prescription drugs with other self-care products of comparable level of risk. Regulations amending the Food and Drug Regulations, Part C (Agile Regulations for Licensing Drugs, including Self-Care Framework Phase 2 and the Use of Foreign Decisions)
• Phase III – Introduce for consultation, regulatory amendments to address: evidence standards for similar health claims; extending risk-based regulatory oversight; and, seeking additional powers for Health Canada such as the ability to require a recall or label change for all self-care products.
IMPORTANT TO NOTE: Although there has been some delay in the Self-Care Framework due to Covid-19, your CA Team was successful in having some of the important benefits of Self-Care included in CUSMA (e.g. elimination of quarantine and re-testing provisions on our imported DIN products) which has now been in place since July 1st. It is estimated that this saves on average some $100K per year per SKU requested. We have also requested some additional interim relief measure that can administratively be put in place to further reduce unnecessary regulatory burdens while the formal implementation of the Framework is completed.