Health Canada is the authority to approve the marketing of new drugs in Canada. For the assessment of the safety and efficacy information of the drug from clinical trials, generally time duration of 2 to 4 years is taken. However, each province must still choose whether or not to compensate for the cost of the new drug even after it has received the approval for marketing.

Health Canada’s Drug Approval Process (Approved Drugs in Canada):

To qualify for drug approval innovative drug manufacturing companies must follow a specified process as under:

Step 1: In order to obtain permission to conduct clinical trials in Canada, the developer of the drug submits an application to Health Canada.

Step 2: The developer of the drug can submit a New Drug Submission to the Health Products and Food Branch (HPFB) if clinical trials show that the new drug’s potential benefits are more than the risks associated with it.

Step 3: A detailed review of clinical trial data provided in the New Drug Submission on drug safety & efficacy is performed by health Canada.

Step 4: The drug manufacturing company is allowed to market the product in Canada if the findings by Health Canada show that the benefits associated with the applicant drug are more than the risks involved (Adverse Effects).

Information provided by Chemxpert for Approved Drugs in Canada

  • Active ingredients: Active ingredient of the drug
  • Application No: Application no. for the approved drug
  • Brand Name: Trade name or the proprietary name of the product
  • Market Status: Active (RX), over the counter or discontinued
  • Applicant Name: Individual, pharmaceutical manufacturing company, research institute or lab holding the patent for the product.
  • Class: Human or veterinary
  • Dosage Strength: Dosage strengths of the approved drug in mg

For Paracetamol Chemxpert has 169 products registered in Canada