Ask Jean: Natural Health Products and Homeopathic Medicines
15 June 2022
Clinical Trials BC Chronicle Summer 2022 – by Jean Smart, Regulatory Affairs and Quality Officer, Clinical Trials BC
What is the difference between a natural health product and a homeopathic medicine, and do we have to do clinical trials on them?
It is a very timely question. The answer is in two parts.
Part 1 – What are they?
You will find Schedule 1, the Natural Health Products Regulations (NHPR) and what is not a Natural Health Product by way of exclusion clauses in Schedule 2. Beware of Schedule 2.
A natural health product (NHP) as defined, is a substance or a combination of substances in which all the medicinal ingredients are substances (noted in Schedule 1), a homeopathic medicine or a traditional medicine, which is manufactured, sold, or represented for use in:
- the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
- restoring or correcting organic functions in humans; or
- modifying organic functions in humans.
Examples listed are:
- Herbal remedies
- Vitamins and minerals
- Homeopathic medicines
- Traditional medicines such as traditional Chinese medicines
- Other products like amino acids and essential fatty acids
A homeopathic product (HP) is a type of a natural health product (NHP) based on homeopathy. Homeopathic products must be manufactured from, or contain as medicinal ingredients, only those substances referenced in a recognized ‘homeopathic monograph’ in an ‘approved homeopathic pharmacopoeia.’ There is a list of approved monographs and pharmacopoeia. In addition, Homeopathic products must be prepared in accordance with the methods outlined in an approved homeopathic pharmacopoeia (follow the recipe!). This is based on the definition of “homeopathic medicine” in the Health Canada ‘Evidence for Homeopathic Medicines’ guidance document.
There is a way to tell the difference of an approved marketed Natural Health Product and a specialized homeopathic product. A Homeopathic product has a ‘DIN-HM’ instead of a Natural Product Number ‘NPN’ as its product number. These labels show that the products have been evaluated by the NNHPD and approved for sale in Canada.
Part 2 – Are clinical trials required for NHP and HPs?
The answer is: Yes Maybe No.
Not all clinical trials of NHPs require authorization from Health Canada. Part 4 of the NHPR is to ensure:
- The safety, efficacy, and quality of both the CT protocol and the investigational product(s) and placebo/comparator given during the study
- The safety of clinical trial subjects and other people
- Compliance with ICH, Good Clinical Practice (GCP) and federal and provincial laws.
- That people with suitable expertise conduct properly designed CTs
More Information on GCP can be found down in section 74 of the NHPR or in the ICH Guidance Document Good Clinical Practice: Consolidated Guideline: ICH Topic E6
There is a guidance document that includes information on which types of clinical trials of NHPs do not require authorization. It is written in the negative and should be read in parallel with the Natural Health Product Regulations.
Note: The regulations pertaining to Natural Health Products were amended on 06 July 2022. The definition of homeopathic product and natural health product were not changed. See the Regulatory Update for more information on the changes to the Regulations that affect clinical trials.
Amendments to the Natural Health Products Regulations [2022-07-06]