Catalogue - Canadian Urban Data Catalogue (CUDC)

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Catalogue Entry: Generic submissions under review

How to access a list of generic drug submissions currently under review.
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Catalogue Entry: How Drugs are Reviewed in Canada

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.
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Catalogue Entry: Guidance on Drug Establishment Licences (GUI-0002)

These guidelines are meant to help companies in the drug manufacturing industry and health care professionals understand how to comply with regulations, specifically drug...
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Catalogue Entry: Service Standard for the Right to Sell Drugs under the Food and Drug Regulations

Before a drug is authorized for sale in Canada, it must be issued a DIN in accordance with the Food and Drug Regulations. Also in accordance with the Food and Drug Regulations,...
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Catalogue Entry: Clinical information on drugs and health products

Drug and medical device manufacturers submit clinical information to Health Canada for the approval of new products. Health Canada assesses this clinical information to reach a...
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Catalogue Entry: Public release of clinical information

We are updating how we disclose the clinical information used to assess the safety and effectiveness of drugs and medical devices.
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Catalogue Entry: Good Clinical Practices

These inspection and investigation functions have as main objective to reduce risks to subjects enrolled in clinical trials, while encouraging sponsors in their research...
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Catalogue Entry: Medical devices

The term Medical Devices covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical...
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Catalogue Entry: Safe Medical Devices in Canada

The Medical Devices Bureau of the Therapeutic Products Directorate (TPD) is the national authority that monitors and evaluates the safety, effectiveness and quality of...
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Catalogue Entry: Canada's Access to Medicines Regime

Canada's Access to Medicines Regime provides a way for the world's developing and least-developed countries to import high-quality drugs and medical devices at a lower cost to...
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Catalogue Entry: Guidance on Medical Device Establishment Licensing (GUI-0016)

This guidance document is intended for any person in the medical device industry and it provides guidance on regulatory requirements in relation to Medical Device Establishment...
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Catalogue Entry: Guidance on Medical Device Compliance and Enforcement (GUI-0073)

This document outlines the strategy and provides guidance for the medical device industry on Health Canada's compliance and enforcement activities.
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Catalogue Entry: Canada's Access to Medicines Regime background

In August 2003, negotiations among World Trade Organization (WTO) members resulted in a landmark decision to waive two licensing provisions of the WTO Agreement on Trade-Related...
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Catalogue Entry: Canada's Access to Medicines Regime documents

This section contains additional information and documentation.
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Catalogue Entry: Company requirements under Canada's Access to Medicines Regime

To participate in the Regime, a pharmaceutical company must enter into a sales agreement with an eligible importing country for the purchase of a specified amount of an eligible...
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Catalogue Entry: Process map for preparing to submit an application under Canada's Access to...

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company that is preparing to submit an application for a compulsory licence...
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Catalogue Entry: Process map of terms and conditions of a compulsory licence under Canada's...

This process map provides a visual overview of the steps that need to be followed by a pharmaceutical company to meet the terms and conditions of a compulsory licence under...
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Catalogue Entry: Royalty payments and Canada's Access to Medicines Regime

A pharmaceutical company that holds a compulsory licence under Canada's Access to Medicines Regime is required to pay royalties to the patent holder. The company must make...
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Catalogue Entry: Submit an application under Canada's Access to Medicines Regime

The company must submit the application package to the Commissioner of Patents at the Canadian Intellectual Property Office (CIPO).
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Catalogue Entry: Declare identity and patent status of pharmaceutical product under Canada's...

The pharmaceutical company must complete and submit to the Commissioner of Patents one of the forms listed below. The company should choose the form that corresponds to the...
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You can also access this registry using the API (see API Docs).

2,907 catalogue entries found