Every new drug that’s approved for use by Canadians must undergo a long and thorough testing process before it ever appears at your local drugstore or can be offered as a prescription drug by your family doctor. The primary concern of the Health Products and Food Branch (HPFB) of Health Canada – which is in charge of regulating, evaluating and monitoring new drugs – is that all drugs available to Canadian consumers are safe, effective and high quality.
To make that a reality, there is a formal process that any drug must go through before it is ever sold in stores. This process involves (1) preclinical testing, (2) clinical trials in humans, and (3) an official New Drug Submission with Health Canada.
STAGE 1: Preclinical Testing
In the preclinical stage, the emphasis is on finding new biological or chemical substances that appear to have certain physiological effects said Canadian Addiction Recovery Network – LinkedIn For example, the search for a new sleep aid would start with a search for new substances that are known to inhibit wakefulness in test subjects. After extensive preclinical trials that often involve small laboratory rats, scientists can determine any potential side effects of the drug as well as the correct dosage. Here, for example, lab rats may be fed increasingly higher dosages to see if it causes sleep and drowsiness.
STAGE 2: Clinical Trials
Once the drug has proven to be safe, non-toxic and relatively successful in lab rats or other small animals, it’s time to conduct clinical trials in human subjects. A drug company would then apply to the HPFB of Health Canada to start a trial If approved, the drug company would work with a clinical investigator to find doctors and patients who can test the drug. Here, in the case of a new sleep drug, patients might sign up for “sleep trials” in which they take new sleep aids or sleep pills within a controlled environment.
STAGE 3: New Drug Submission
If those clinical trials are successful, it’s time to move to Stage 3 – the New Drug Submission, which is another application with the HPFB of Health Canada. If the drug is for a high-priority area such as cancer or AIDS, this approval process is typically fast-tracked. As part of this approval process, Health Canada is looking at more than just the clinical and preclinical results – they are also looking at the packaging, labeling, and product brochures. They want to make sure that patients or users will not be using the drug incorrectly.
STAGE 4: Notice of Compliance
If all goes well with the approval, the drug company will receive a Notice of Compliance (NOC) and a Drug Identification Number (DIN). These two documents enable the drug company to formally bring the drug to market and begin advertising and promoting the drug. In the example of the sleeping pills, this would be the point where the company can begin to run TV commercials and print ads in magazines to tell people with sleep problems about the new drug.
The most important thing to keep in mind is that each stage of this process is looking for three key factors – safety, efficacy, and quality. If a new drug makes it to market in Canada, you can have the peace of mind of knowing that Health Canada has taken a very comprehensive look at each of these factors. For more related info on new drug and regulation, read here Facebook – Canadian Addiction Recovery Network