Catalogue - Canadian Urban Data Catalogue (CUDC)

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Catalogue Entry: Donating and using third-party sperm or ova (eggs) for assisted human reproduction

Donor sperm and ova (eggs) are sperm and ova that are intended for use in assisted human reproduction (AHR) by a recipient who is not the spouse, common-law partner or sexual...
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Catalogue Entry: Guidance Document for Source Establishments - Reporting Adverse Reactions to...

This guidance document provides source establishments with assistance on how to comply with adverse reaction reporting obligations under the Food and Drugs Act and the Safety of...
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Catalogue Entry: Mandatory reporting of serious adverse drug reactions and medical device...

The purpose of this guidance document is to provide hospitals with information that may be useful in achieving compliance with the federal regulatory requirement for hospitals...
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Catalogue Entry: Guidance Document - Human-Use Antiseptic Drugs

An antiseptic product is considered to be one that inactivates, reduces, prevents or arrests growth of microorganisms with the inherent intent to mitigate or prevent disease....
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Catalogue Entry: Notice: Guidance Document - Data Requirements for Safety and Effectiveness...

This guidance document provides sponsors of subsequent entry inhaled corticosteroid (ICS) products for the treatment of asthma with information on the comparative clinical data...
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Catalogue Entry: Notice: Policy on Bioequivalence Standards for Highly Variable Drug Products

This Notice serves to inform sponsors of drug submissions pursuant to Division C.08 of the Food and Drug Regulations (that is [i.e.], new drug and abbreviated new drug...
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Catalogue Entry: Prohibitions related to Purchasing Reproductive Material and Purchasing or...

The AHR Act forbids the buying and selling of in vitro embryos in Canada.
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Catalogue Entry: Inspection approach for blood establishments (POL-0039)

The purpose of this document is to describe Health Canada's approach for inspecting blood establishments in order to assess their compliance with the Food and Drugs Act (the...
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Catalogue Entry: Reporting a complaint for the Assisted Human Reproduction Act

Health Canada is committed to verifying complaints from Canadians and industry regarding materials, activities or any matters which are subject to the Assisted Human...
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Catalogue Entry: Reimbursing a sperm or ova (egg) donor or a surrogate for expenditures...

In Canada, it is illegal to purchase sperm or eggs from a donor (or person acting on behalf of a donor) or pay a female person to be a surrogate. However, donors and surrogates...
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Catalogue Entry: Toward a strengthened Assisted Human Reproduction Act

This consultation document provides an overview of the key policy proposals that will help inform the development of regulations to support bringing into force Section 10,...
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Catalogue Entry: Consent to Use Human Reproductive Material and In Vitro Embryos

Under section 8 of the AHR Act, donors of human reproductive material and in vitro embryos must provide their written consent before their material can be used to create an...
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Catalogue Entry: Prohibitions related to Surrogacy

Under section 6 of the AHR Act, no person shall pay, offer to pay or advertise that they will pay a woman to be a surrogate mother.
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Catalogue Entry: Prohibitions related to scientific research and clinical applications

Under section 5(1) and section 9 of the AHR Act, no person shall knowingly create a human clone by using any technique, or transplant a human clone into a human being or into...
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Catalogue Entry: Revised Guidance Document: Acetaminophen Labelling Standard

Health Canada Revised Guidance Document - Acetaminophen Labelling Standard
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Catalogue Entry: Summary: Guidance Document - Administrative Processing of Submissions and...

To clarify the requirements for eligible drug submissions and applications that will be processed under the administrative pathway.
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Catalogue Entry: Notice: Clarification of bioanalytical method validation procedures

The purpose of this notice is to clarify Health Canada’s interpretation and expectations for all matrix-based stability experiments [that is (i.e.) Long term, Freeze-thaw and...
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Catalogue Entry: Guidance Document: Conduct and Analysis of Comparative Bioavailability Studies

To provide sponsors of new drug submissions with the information necessary to comply with Sections C.08.002(2)(h), C.08.002.1(2)(c)(ii) and C.08.003(3) of the Food and Drug...
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Catalogue Entry: Draft Guidance for Industry: Preparation of Comparative Bioavailability...

The purpose of this guidance is to define the Common Technical Document (CTD) format of drug submissions which rely on comparative bioavailability studies to establish safety...
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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 key obligations under the Food and Drug Regulations (FDR) for various types of cannabis-based clinical...
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2,942 catalogue entries found