Canada is not only an extremely developed country in medical pharmacy and nutrition, but the quality of health care products is among the best in the world. The bottom line is the strict management of the national health care product market: production, approval, certification, quality control and supervision are more scientific, and regulations And the review procedures are more stringent and standardized. The purpose of this is to allow manufacturers and businesses to objectively and realistically introduce the functions of health care products through legal channels, resolutely sanction exaggerated publicity and prevent magical health care functions, so as not to mislead or deceive consumers.
People who have lived in Canada for a long time will notice that you rarely see advertisements for medicines and health products on TV or in newspapers and magazines, especially for health products. The Canadian government's review of this is very strict, to ensure the safety and vital interests of consumers, even more cautious than the United States.
So how does the Canadian government regulate the health care product market?
The scope of legislative supervision includes product definition, product license management, site license management, clinical trials, labeling and packaging, advertisements, adverse reaction reports, etc.
Before January 2004, Canadian health care product supervision followed the "Federal Food and Drug Act." Although this regulation is considered to be the most stringent and standardized pharmaceutical product supervision regulation in the world, it does not supervise the health care product market. Not very applicable. This is because many health products are produced and sold under the banner of "habitual therapy preparations" and "functional foods" rather than drugs. The producers have pharmaceutical factories and food factories, and the distributors have both pharmacies and food stores as well as supermarkets and stores. The regulation of the Food and Drug Law is like fighting mosquitoes with anti-aircraft guns.
In response, Canada promulgated the "Canadian Federal Natural Health Products Legislation Regulations (NHPR)", which came into effect on January 1, 2004.
According to this new regulation, health functional foods (NHPs) include traditional herbs, "homeopathic medicines", vitamin and mineral health products, herbal supplements, amino acids, plant extracts and essential fatty acids, and their use is defined as Disease diagnosis, treatment, alleviation or prevention of body dysfunction and body abnormalities or related symptoms; restoration and correction of body tissue functions; restoration, maintenance or promotion of human health conditions, and assisting body function recovery.
According to the regulations, all health functional foods must pass GMP requirements and obtain product licenses before they can be sold. License applicants must submit detailed information including the product's medicinal composition, source, function, non-medicinal composition and recommended use to the federal government. Ministry of Health, the latter will complete the review within 60 days from the date of submission of the materials and issue product licenses to those who meet the requirements. The license number is a combination of letters and numbers starting with NPN (Natural Health Product Series) or DIN-HM (Traditional Herbal Medicine or Homeopathic Medicine Series). The health products sold must be marked with the license number in a prominent place.
Not only that, the regulations impose license requirements on packaging, label manufacturers, and health care product importers. These companies can only operate, sell, store and transport health care products after obtaining the corresponding site license. The regulator requires that the site be obtained. The license site must have health care product wholesale records, product recall records, and detailed records of product handling, storage and transportation that are available for inspection at any time.
The regulations stipulate that if a health care product has a serious adverse reaction in or outside Canada, the distributor must notify the Federal Ministry of Health within 15 days of being aware of the reaction. The Ministry of Health shall make a safety assessment as soon as possible and decide on the response measures, including stopping Sales, mandatory recalls, and revocation of licenses.
Through a series of strict regulations in the Canadian Federal Natural Health Products Legislation Regulations (NHPR), the Canadian Federal Ministry of Health has incorporated the entire process of classification, production, sales, storage and transportation of health products into the scope of supervision, and has taken account of ingredients, labels and publicity standards. Quantification standards have been put forward on the basis of functions and functions, which are concentrated on a label and a license serial number, which not only facilitates supervision and verification, but also facilitates consumers’ inquiries and supervision.
Through the license-based management model, government departments “nationalize” the review and interpretation powers of key elements such as the functions, efficacy, and side effects of health products. The manufacturers’ responsibilities are limited to making their products comply with their own declarations. The label is "officially approved" and can be freely promoted within the scope of the label.
In this way, if something goes wrong with a health product, the relevant parties will first determine whether the product quality and ingredients meet the label and license standards. If they do not, the responsibility rests with the manufacturer and distributor; otherwise, it is entirely the responsibility of the government.
Because of this, the monitoring of health care products, especially the monitoring of various ingredients, is very strict. This relates to the "big right and wrong" of who should bear the responsibility if quality problems or effect disputes arise, and the standards and results of such testing , The media and the public can use a label and a license number to search for it according to the map, and it is clear that "fuzzy philosophy" is not only impossible, and it does no good to anyone.
Since Canada classifies health care products as functional foods, the supervision is mainly about ingredients, and if the ingredients exceed the standard, it will be resolutely punished. It is relatively insensitive to soft and non-indicative things. Therefore, Canadian health care products can be said to be "curative", but testing is not. There can only be one official result, and it is impossible for the "Rashomon" phenomenon of the two official test results to occur. What the latter can learn from is the quantification, meticulousness and operability of such regulations, the clarity of responsibilities, and the "high visibility" of various standards, inspections, and supervision.
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