Regulatory update: Summer 2022
25 July 2022
Clinical Trials BC Chronicle Summer 2022 – by Jean Smart, regulatoryaffairs and quality officer, Clinical Trials BC
A regulation amendment to the Natural Health Product Regulations was filed (June 21, 2022) and posted on 06 July 2022. This has happened after posting of the draft last summer and extensive consultation initiatives. Two associated guidance documents to support the amendment have also been issued.
The NHPR Amendment
The purpose of the NHPR amendment is to make product labels easier to read and understand. These changes support Canadians in selecting and using NHPs safely. The changes were also made to align with other regulatory authorities in the EU, Australia (ACCESS associated regulatory authorities) and the United States.
The amendments related to Clinical Trials are Amendment 14 and 15.
It involves a repeal, clarification that the sponsor has obligation to act in accordance with an amended authorization and finally a requirement to maintain specific records.
Guidance for Evidence for Homeopathic Medicines
Health Canada has also updated the evidence requirements for homeopathic medicines, a type of NPH, to align with products making similar claims. There are three changes:
1.2 Evidence to support the use of homeopathic medicines
There must be evidence to support the safety, efficacy and quality of a homeopathic medicine, as per Section 5(g) of the NHPR. This will include clinical data or a clinical trial.
3.2 Evidence to support a specific recommended use or purpose
Sufficient evidence must be provided to demonstrate a clear rationale for the inclusion of each medicinal ingredient in the homeopathic medicine. For a homeopathic medicine with a specific recommended use or purpose (claim), evidence must link each medicinal ingredient to the symptom(s) of the claim it is intended to address. T
Appendix 4 Addition
The new appendix provides examples of homeopathic medicines with higher-risk homeopathic product claims, which relate to a disease or condition that is non-self resolving or self-limited and has potential for harm if the product is underperforming.
Guidance for labelling of Natural Health Products
This updated guidance document provides information on label design specifications, required sections of the Product Facts Table (PFT), and labelling content to meet regulatory requirements under the Regulations. It replaces the previous Labelling Guidance Document published in 2006.
References and Links
- Government of Canada, Health Canada Amendment to the Natural Health Products Regulations, Food and Drugs Act, Registration, SOR/2022-146. June 21, 2022.
- Health Canada, Guidance: Labelling of Natural Health Products. 06 July 2022.
- Health Canada, Guidance: Evidence for Homeopathic Medicines. 06 July 2022.
Evidence for Homeopathic Medicines guidance document [2022-07-06]
- Health Canada, Guidance: Clinical Trials for Natural Health Products, modified 06 July 2022.
- Regulatory buffs can find the ‘A history on Natural Health Products Regulations’ in the Government of Canada Archive.