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Open data is defined as structured data that is machine-readable, freely shared, used and built on without restrictions.

The key things to remember about open data are:

  • #Availability and access#: the data must be available as a whole and at no more than a reasonable reproduction cost, preferably by downloading over the internet. The data must also be available in a convenient and modifiable form.
  • #Re-use and redistribution#: the data must be provided under terms that permit re-use and redistribution including the intermixing with other datasets.
  • #Universal participation#: everyone must be able to use, re-use and redistribute. There should be no discrimination against fields of endeavour or against persons or groups. For example, 'non-commercial' restrictions that would prevent 'commercial' use, or restrictions of use for certain purposes (e.g. only in education), are not allowed.
47494 records

The scope of this risk based interim policy regarding the Clinical Trial requirements is limited to classical FMT (fresh or …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical-trial requirements classical FMT fecal microbiota therapy treatment of clostridium-difficile-Infection not-responsive to conventional-therapies

As set out in paragraph C.05.010(b) of the Food and Drug Regulations (FDR), clinical trials must follow certain requirements of …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: Management of clinical-trials clinical-trials during COVID-19 clinical-trials during pandemic notice to clinical-trial-sponsors

Pharmacometrics is the science of using quantitative analysis and modelling and simulation (M&S) approaches to inform and enhance drug development …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: pharmacometrics drug submissions clinical trial applications quantitative analysis modelling-simulation approaches quantitative system pharmacology model-informed drug-development approaches

This Ministerial Order (MO) will give Health Canada an additional 15 days to review all clinical trial applications and amendments …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical trial clinical trial applications-amendments Ministerial Order clinical-trial review period extend review period

Drugs intended for use in clinical trials in Canada are regulated under Division 5 of Part C of the Food …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: good manufacturing practices guidance document drugs-used in clinical-trials GUI-0036

This labelling standard describes the requirements necessary to receive marketing authorization (a Drug Identification Number (DIN)) for oral decongestant non-prescription …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: Guidance Document non-prescription Oral-Adult-Decongestant cough and cold labelling standard

These guidelines will help all persons (individuals and companies) who store and/or transport drugs to comply with Canada’s Food and …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: Guidelines GUI-0069 environmental-control of drugs drug storage and transportation

This refers to the situation where a clinical trial is not initiated by a commercial sponsor. In this case, the …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: clinical trial sponsor institution or investigator investigator initiated clinical-trials commercial sponsor investigator regulatory-responsibilities

This Notice serves to inform clinical trial sponsors that Health Canada will publish information about all clinical trial applications (CTAs) …

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: publication of information information about clinical-trial-applications clinical trial applications CTAs clinical trial sponsors

This document is intended to describe the appropriate mechanisms to address drug submission-related disputes.

Record Modified: Jun 7, 2022
Record Released: Jun 7, 2022
Publisher: Health Canada
Formats: HTML
Keywords: reconsideration of decisions human drug submissions drug submission-related disputes