An Overview of the New Drug Submission and Approval Process for Canada

An Overview of the New Drug Submission and Approval Process for Canada
Author(s):
Manoj Rajaram Patil, Lokesh Kothari, Atish Mundada
Keywords:
NDS, Canada Drug approval Process, Health Canada, Regulatory Body, New drug Submission and Approval Process, Pharmaceutical market
Abstract
Health Canada is a 9th largest growing pharmaceutical market in the world. The Health Canada is the regulatory Authority of Canada that works under department of Minister of Health. Health Canada is responsible to approve the New Pharmaceutical Drug in Canada under the Food and Drug Branch with applicable Food and Drug Act and its Regulations. The health Canada is also responsible for approval or rejection of the various types of applications related to drug in Canada. There are Various submission types are there in Health Canada i.e., NDA, SNDA, ANDA, SANDA. In the present review article, we will discuss about the New Drug Submission and approval process in Canada.
Article Details
Unique Paper ID: 161005 Publication Volume & Issue: Volume 10, Issue 2 Page(s): 310 - 315
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