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Found 10 records similar to Guidance for Industry - Priority Review of Drug Submissions
Present the list of new drug submissions (NDSs) that are currently being reviewed.
How to access a list of generic drug submissions currently under review.
Modified requirements for COVID-19 drugs allow for the filing of rolling submissions (section C.08.002(2.3) of Canada's Food and Drug Regulations). The ability to review data from early development while later-stage clinical trials are taking place helps to expedite the regulatory review process.
This project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access to drugs, including drugs for rare diseases.
This guidance document provides clarification to submission sponsors on how to comply with (Veterinary Drugs Directorate of Health Canada) VDD's policies, governing statutes and regulations.
For eligible submissions accepted into review on or after October 1, 2018, the submission 'class' added to the Lists of submissions currently under review.
This Guidance Document is to be used in the preparation of Veterinary Drug Submissions for presentation to Health Canada. Some sections of this Guidance Document are general in nature. Therefore, this Guidance Document should be used in conjunction with the complete Food and Drugs Act and Regulations, and with specific Health Canada Policies and Guidance Documents applicable to veterinary drugs.
Health Canada's drug products fact sheet describes how drugs are reviewed in Canada including how drugs are developed and submitted for authorization to conduct clinical trial.
This guidance document is intended to provide sponsors with an outline of the chemistry and manufacturing, clinical, and human safety requirements for the filing of the following submission types with the Veterinary Drugs Directorate (VDD): Abbreviated New Drug Submission (ANDS); Changes to ANDS - Supplemental Abbreviated New Drug Submission (SANDS) and Notifiable Change (NC).
Following several successful joint reviews between Australia, New Zealand and Canada, there has been interest by others within industry to explore this as a model for bringing new veterinary drug products to market. Industry has been keen to understand how to initiate discussions and how the overall process would work. This document is therefore provided as guidance for industry about the joint review process for veterinary drugs.