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Found 10 records similar to Regulatory Modernization Submissions 2019
From November 25, 2017 to January 8, 2018, the Government of Canada invited stakeholders to share their views on how to address regulatory differences between the US and Canada through the Regulatory Cooperation Council. In particular, Canadians were invited to comment on issues to be considered for future cooperation, including proposals to align existing regulatory systems, streamlining of unnecessary or duplicative procedures, and areas that will be impacted by new technologies, which are not yet regulated.
From November 4 to December 4, 2017, the Government of Canada consulted Canadians on ideas for reconciling regulations across Canada where differences impose greater costs on businesses and industry, and affect labour mobility in Canada. This consultation was undertaken to support the federal government’s participation in the Canadian Free Trade Agreement's Regulatory Reconciliation and Cooperation Table. Canadians, businesses, and other stakeholders were encouraged to submit suggestions for regulatory reconciliation and regulatory cooperation items which focused on existing regulations that act as a barrier to trade, investment, or labour mobility within Canada.
From February 10, 2018 to April 11, 2018, the Government of Canada invited comments from all stakeholders on potential areas for regulatory cooperation with the E.U. under the newly established Canada-E.U. Comprehensive Economic and Trade Agreement Regulatory Cooperation Forum. This consultation included soliciting proposals on how to: align existing regulatory systems; streamline duplicative procedures; and/or work collaboratively in areas that are not currently regulated, such as emerging technologies.
This guidance aims to articulate Health Canada's expectations and generate a level of consistency regarding the interpretation of the Priority Review of Drug Submissions policy and the filing of a Priority Review request. Additional clarification of the process by which the Priority Review request is assessed is provided.
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 document is intended to describe the appropriate mechanisms to address drug submission-related disputes.
Health Canada has adopted the International Conference on Harmonization (ICH) guideline Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories, ICH Topic E15.
The Common Electronic Submissions Gateway (CESG) is a method of securely providing regulatory transactions for review in the electronic Common Technical Document (eCTD) format
How to access a list of generic drug submissions currently under review.
(DIN) has been assigned for that drug and the assignment of the number has not been cancelled pursuant to section C.01.014.6. In the case of a new drug, a new drug submission filed pursuant to Division 8 of the Food and Drug Regulations is regarded as an application for a DIN. When a product is not subject to Division 8, the application is called a DIN submission.