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Catalogue Entry: How to comply with procedures under Canada's Access to Medicines Regime
Instructions for complying with the Requirements of Canada's Access to Medicines Regime specify how to notify the World Trade Organization or the Government of Canada, and how...-
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Catalogue Entry: Role of Non-Governmental Organizations in Canada's Access to Medicines Regime
The Government of Canada regards non-governmental organizations (NGOs) as valuable resources and actively consulted with them when designing Canada's Access to Medicines Regime.-
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Catalogue Entry: Anti-diversionary measures under Canada's Access to Medicines Regime
Canada's Access to Medicines Regime includes a number of measures to prevent diversion of drugs and medical devices to unintended markets.-
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Catalogue Entry: Capacity to manufacture under Canada's Access to Medicines Regime
To participate in the Regime, an eligible importing country must declare that it has insufficient or no pharmaceutical manufacturing capacity in relation to the specific product...-
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Catalogue Entry: Least-developed countries eligible to import under Canada's Access to...
It presents the list Least-Developed Countries Eligible to Import Under the Regime.-
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Catalogue Entry: WTO-member countries and non-WTO member countries eligible to import under...
It presents WTO-Member Countries and Non-WTO Member Countries Eligible to Import Under the Regime.-
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Catalogue Entry: Features of Canada's Access to Medicines Regime
Below are some of the unique features of Canada's Access to Medicines Regime, many of which resulted from negotiations between the Government of Canada, the private sector and...-
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Catalogue Entry: Regulatory Initiative: Amendments to the Food and Drug Regulations -...
These amendments would introduce a regulatory framework for Drug Shortages within the Food and Drug Regulations.-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Notice to industry -...
The Health Canada and Health Technology Assessment (HTA) review processes are independent of each other. Aligned reviews project will make sure that the timing of Health Canada...-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Early scientific...
This project will result in Health Canada and Health Technology Assessment (HTA) organizations working together. This will allow them to give scientific advice to manufacturers...-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Expanding priority...
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,...-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Improving access to...
The updated regulations will help drug makers understand what information should be included in their drug submissions. This will help with product approval and availability.-
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Catalogue Entry: Improving the regulatory review of drugs and devices: Drugs - Special Access...
The Special Access Programme (SAP) provides access to nonmarketed drugs for practitioners treating patients with serious or life-threatening conditions when conventional...-
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Catalogue Entry: Guidance Document: Administrative Processing of Submissions and Applications...
For the purpose of this guidance document, Health Canada has determined that certain submissions and applications involving human or disinfectants drugs may be submitted for...-
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Catalogue Entry: Public Release of Clinical Information: consultation
We are working to make clinical information about the safety and efficacy of drugs and medical devices available to the public. Information that Health Canada currently treats...-
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Catalogue Entry: Country access to Canada's Access to Medicines Regime
Countries with insufficient or no manufacturing capacity in the pharmaceutical sector can benefit from participating in Canada's Access to Medicines Regime. Under the Regime,...-
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Catalogue Entry: Compulsory licences under Canada's Access to Medicines Regime
Governments can override patent rights when necessary. In such instances, the government authorizes a third party to use the patented invention without the patent holder's...-
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Catalogue Entry: WTO-member countries eligible to import under Canada's Access to Medicines Regime
It presents WTO-Member Countries Eligible to Import Under the Regime-
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Catalogue Entry: Guidance document on Public Release of Clinical Information: profile page
The purpose of this guidance document is to give drug and medical device manufacturers instructions on how to prepare clinical information documents for release and give members...-
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Catalogue Entry: Guidance Document: Considerations for Inclusion of Women in Clinical Trials...
This document provides guidance on the study and analysis of sex differences in clinical trials of therapeutic products in order to generate evidence to advise on the optimal...-
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