Health Canada doesn’t test if a homeopathic product works, or if it has any active ingredient. Instead, it relies on something called the Homeopathic Pharmacopoeia – a sort of recipe book of how to make remedies based on tradition and observation. So far, Health Canada has issued drug identification numbers to over 6,000 homeopathic medicines.
Health Canada provided this additional information to Marketplace relating to their regulation of homeopathic medicine:
Q: How are homeopathic remedies licensed? What info has to be provided in order to get a DIN/NPN number? What is involved in testing for safety and efficacy?
A: To be legally sold in Canada, homeopathic medicines (HMs), like all other natural health products (NHPs), must comply with the licensing and labelling requirements of the Natural Health Products Regulations.
The onus is on the manufacturer or importer to apply for a licence to Health Canada and to supply the necessary evidence to support the safety, efficacy and quality of their homeopathic product. Health Canada in turn will assess the evidence provided to determine whether or not it is sufficient to support the product under its recommended conditions of use.
The evidence required to support the safety, efficacy and quality of a given product depends on a number of factors, including the product’s ingredients, the number and nature of the claim(s) being made as well as the overall risk of the product.
For HMs, the types of acceptable evidence range from references to one of five recognized homeopathic pharmacopoeias (e.g. a standard product with a general claim) to other homeopathic sources, including clinical trial data (e.g. in the case of a product specific claim for a serious condition).
Homeopathic pharmacopoeias are standards that set out specifications (i.e. safe uses, doses, methods of preparation, dilutions, etc.) for specific homeopathic ingredients.
Further information on the evidence requirements for HMs is available in Health Canada’s Evidence for Homeopathic Medicines guidance document (see: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/ehmg-nprh-eng.php)
Q: Is there any way of finding out how many products are currently approved with a DIN/NPN as a homeopathic remedy. How many have actually been licensed as a homeopathic remedy?
A: To date, Health Canada has licensed 6431 homeopathic products with a DIN-HM. Of this total, 5874 were licensed as products with non-specific “homeopathic remedy” claims (i.e. the label simply states “homeopathic remedy”). The other 557 are HMs that have been licensed with specific claims.
Q: Does Health Canada test to see if the homeopathic medicine contains any active ingredient or does Health Canada rely solely on the homeopathic pharmacopeia for information on how the product is supposed to be manufactured?
A: Health Canada does not conduct any tests on homeopathic medicines.
As part of the evidence provided in support of a product licence application for market authorization, the applicant must provide product specifications outlining which identity tests were done to demonstrate that the medicinal ingredients listed on the label were indeed what was intended to be used to manufacture the product.
Health Canada for its part validates the testing methods used to confirm the identity of the ingredients.
Please note that due to the nature of homeopathic medicines, namely its potential to be highly diluted, applicants are required to do the identity testing at the raw material stage for the medicinal ingredients of homeopathic medicines.
Q: For the majority of homeopathic products which have been licensed and given a DIN-HM-(non-specific claims) — does Health Canada conduct any tests to confirm efficacy?
A: Health Canada does not conduct any tests on these “non-specific claim” homeopathic medicines.
The onus is on the applicant seeking market authorization to provide evidence supporting the safety and efficacy of the product.
In the case of non-specific claim homeopathic medicines, no pre-market assessment for efficacy is conducted as there are no claims to evaluate.
Q: How does Health Canada guarantee the efficacy of products in which the active ingredient has been highly diluted?
A: Health Canada assesses the evidence provided by the applicant to determine whether or not it sufficiently supports the safety and efficacy of the proposed claims and recommended conditions of use.
Health Canada considers a number of factors when assessing the evidence, such as: its credibility; quality; adequacy, and strength.
If the evidence is deemed insufficient, the product will not be authorized for sale in Canada.
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