Who decides whether a medication is safe enough to be sold to the public? In Canada, Health Canada makes this decision. Health Canada is the federal government department responsible for reviewing all applications for new medications and deciding which ones are safe and effective enough to be sold in Canada.
To get permission from Health Canada to sell a medication in Canada, the sponsor (the person or company taking responsibility for the development of the medication, usually a pharmaceutical company) must submit a package called a "New Drug Submission" to Health Canada. This package must contain an application form, all the pre-clinical and clinical study data, detailed information on how the medication will be manufactured and tested, how the medication will be labeled, and what information will be provided to health care providers and people taking the medication. Often, the package contains thousands of pages of data. The sponsor must also submit a fee to Health Canada to cover the costs of performing the review.
During the review, Health Canada considers the data submitted by the sponsor and may also perform its own testing. Health Canada may also examine studies that have been done in other countries with the same drug. As well, they may consult with medical experts and medical committees outside Health Canada. This review process is also called the "drug approval process." It takes 12 to18 months on average. The process can be faster for medications used to treat life-threatening or debilitating conditions for which there are few effective treatments.
If the medication meets Health Canada's high standards for safety and effectiveness, Health Canada will "approve" it. This means that the medication is considered safe and effective enough to be sold to the public in Canada. The medication will then receive a DIN (drug information number) to identify the medication. The DIN shows that the medication has been approved by Health Canada to be sold in Canada.
Do you have questions about DINs or the way Health Canada reviews new medications? Talk to your doctor or pharmacist.
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