Catalogue - Canadian Urban Data Catalogue (CUDC)

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Catalogue Entry: Comparative Pharmacokinetic Studies for Orally Inhaled Products: Guidance Document

This information will help sponsors comply with the Food and Drug Regulations (Regulations), with respect to comparative studies, with emphasis on in vivo comparative...
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Catalogue Entry: Clinical Trials Modernization: Consultation Paper

Health Canada, the federal regulator of the health products that Canadians rely upon in their daily lives, is responsible for the regulation of clinical trials involving a wide...
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Catalogue Entry: Guidance on applications for COVID-19 drug clinical trials under the...

This section of the guidance outlines requirements for the licence holder after authorization of the clinical trials.
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Catalogue Entry: Guidance on applications for COVID-19 drug clinical trials under the...

This section of the guidance outlines the application processes and guidelines under the Regulations.
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Catalogue Entry: Guidance on applications for COVID-19 drug clinical trials under the...

This section of the guidance outlines the additional requirements for good clinical practices, qualified investigators, and labelling.
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Catalogue Entry: Guidance on applications for COVID-19 drug clinical trials under the...

This section of the guidance outlines additional responsibilites around consent of participants and registration.
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Catalogue Entry: Guidance on applications for COVID-19 drug clinical trials under the...

Guidance for applicants seeking authorization to conduct COVID-19 drug clinical trials.
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Catalogue Entry: COVID-19 protein subunit vaccines

Many vaccines are being studied to see if they will prevent COVID-19, and Health Canada is prioritizing reviews of all COVID-19 vaccine submissions.
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Catalogue Entry: Notice: Confirmation of the Mandatory use of the Regulatory Enrolment...

By way of this update, Health Products and Food Branch (HPFB) is reminding sponsors that the mandatory date for use of the Regulatory Enrolment Process (REP) and the Common...
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Catalogue Entry: Notice: Clinical trials for medical devices and drugs relating to COVID-19...

The Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (Regulations) were published on March 2, 2022. They came into effect on February 27, 2022,...
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Catalogue Entry: Notice to stakeholders: Final guidance document for industry and...

This document gives information on changes made to the Food and Drug Regulations. It was published on October 14, 2020, in Part II of the Canada Gazette. See Regulations...
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Catalogue Entry: Notice to stakeholders: Considerations regarding the proposed use of...

Health Canada is aware of the growing interest in the use of psilocybin, including psilocybin that occurs naturally in certain mushroom species, for potential therapeutic...
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Catalogue Entry: Notice to stakeholders: Considerations regarding the proposed use of...

Health Canada is aware of the growing interest in the use of psilocybin, including psilocybin that occurs naturally in certain mushroom species, for potential therapeutic...
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Catalogue Entry: Notice to Stakeholders – Clarification of Requirements under the Food and...

Health Canada is issuing this notice to clinical trial sponsors to clarify the approach to clinical research with psilocybin. Health Canada recognizes that conducting clinical...
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Catalogue Entry: Notice of Amendment: Tramadol removed from the Prescription Drug List (PDL)

The purpose of this Notice of Amendment is to notify that Health Canada has removed tramadol from the Prescription Drug List (PDL) and added it to Schedule I of the Controlled...
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Catalogue Entry: Notice of Amendment: Revision of Brimonidine on the Prescription Drug List (PDL)

The purpose of this Notice of Amendment is to notify that Health Canada has revised the listing of "brimonidine or its salts" on the Prescription Drug List (PDL). Note that both...
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Catalogue Entry: Notice of Amendment: Prescription Drug List (PDL): Phytocannabinoids

The purpose of this Notice of Amendment is to notify that Health Canada has added phytocannabinoids to the Human and Veterinary Prescription Drug Lists (PDL).
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Catalogue Entry: Notice of Amendment: Prescription Drug List (PDL): Epinephrine (topical solution)

The purpose of this Notice of Amendment is to notify that Health Canada will add Epinephrine topical solution for hemostasis when sold at a concentration equal to or greater...
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Catalogue Entry: Notice – Release of ICH S5(R3): Detection of Toxicity to Reproduction for...

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance...
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Catalogue Entry: Notice – Release of ICH M9: Biopharmaceutics Classification System (BCS)...

Health Canada is pleased to announce the implementation of International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH) Guidance M9:...
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2,942 catalogue entries found