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Commonly Asked Questions about Rt health Canada Forms

The eCTD Submission Process Go to the FDA website and register for an Electronic Submissions Gateway account. Request an application number. Send a sample submission to the FDA. Submit your eCTD via the Electronic Submission Gateway.
Companies are required to file submissions electronically to Health Canada in either Electronic Common Technical Document (eCTD) format or non-eCTD format, depending on the regulatory activity type.
Health Canadas New Drug Submission (NDS) is the process through which new drugs are approved and controlled by the Canadian Health Authority before entering the Canadian market. In Canada, new drugs are regulated under Part C, Division 8 of Food and Drugs Regulations.
Before a drug product is authorized for sale in Canada, the drug manufacturer must submit scientific evidence of the products safety, efficacy, and quality to Health Canada for review and approval.
FDA and Health Canada are regulatory agencies responsible for safeguarding publics health and safety. Their operations are governed by separate legislative systems. While Health Canada is part of the Canadian federal government, the FDA is division of the Department of Health and Human Services in the United States.
WHAT ARE HEALTH CANADAS TIMELINES TO PROVIDE AUTHORIZATION FOR A DRUG TO BE SOLD ON THE CANADIAN MARKET? The Canadian review timeline for a New Drug Submission (NDS) is competitive. Therefore, a total of 355 review days applies, before a sponsor obtains a final review decision.
Electronic submission refers to the submission of a document by electronic means: that is, via e-mail or a web form on the Internet, or on an electronic medium such as a compact disc, a hard disk or a USB flash drive.