Content area
Full Text
ABSTRACT:
The drugs and medical devices for human use in Canada are regulated by Health Canada's Therapeutic Products Directorate (TPD). Health Canada is responsible to implement the rules and regulations for the marketing of drugs. Health Canada's process for approving new drugs is very slow and they give approval for drug products based on a complete review of safety and efficacy data. In Canada, around 70% of the new drugs were submitted over three months, and 40% more than one year, after their first submission. For drugs that were eventually approved to be marketed in Canada and in at least one of the other jurisdictions, the average delay from the first submission in either foreign jurisdiction to submission in Canada was 540 days. A drug approval process is completed by various applications submitted to the authority and the registration of drugs in Canada is really challenging. The purpose of this article is to provide information about the procedure from pre-submission to the marketing of a pharmaceutical drug for obtaining the drug approval in Canada.
KEYWORDS: Health Canada, ANDS, CTA, HPFB, NDS.
INTRODUCTION:
In the regulatory drug approval process a person, sponsor, an innovator, or an organization obtains permission to initiate a new drug in the market. Health Canada is a standard regulatory body to implement guidelines and regulations for registration for the marketing of drugs in Canada. They also implement certain guidelines. Canada has a unique healthcare system which is made up of 13 provisional and territorial programs and 6 additional federal plans. Making healthcare in Canada, share the responsibility between federal, provisional and territorial governments. A drug can take a decade to develop and the regulatory review body may take 5 more years to conduct the reviews1.
The drug approval process includes two different stages i.e. clinical trial phase and marketing authorization period.
The clinical trials stage include 4 phases and after completing these studies the applicant can ensure the safety, efficacy and dose optimization in human beings. The drug application is submitted to the competent authorities by the sponsor, after completing the clinical trials for marketing a new drug. They review the application before approval of a drug for ensuring its safety and efficacy in human beings, the activity of the drug...