Open Government Portal

About this information

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.
47608 records

Health Canada questions and answers regarding applicability and recognition, acceptance of study data and the Standards Council of Canada

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A guidance document non-clinical laboratory-study data drug product applications-and-submissions good laboratory practice

In order to facilitate the implementation of the E3 Guideline, the International Conference on Harmonisation (ICH) Experts have developed a …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A Document clinical study reports ICH Topic E3(R1)

Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E5 …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A Document ethnic factors acceptability-of foreign clinical-data ICH Topic E5(R1)

Q&A Regarding the Adoption of Periodic Benefit Risk Evaluation Report.

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A periodic-benefit-riske-evaluation report PBRER

Guidance on the regulatory requirements for prescription labelling of opioid drugs.

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Q&A prescription opioids sticker-and-handout requirements Pharmacists and Practitioners

Health Canada's approach to the registration and disclosure of Canadian clinical trial information

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: registration disclosure clinical trial information

Regulatory Decision Summaries (RDSs) explain Health Canada's decision for certain health products seeking market authorization.

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: regulatory decision summaries Health Canada's decision health products seeking market authorization

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to: company, dossier and product, regulatory …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: regulatory enrolment process REP filing and processing regulatory information capture information in-a-structured-format

This notice applies to energy-based medical devices for therapeutic or cosmetic indications intended for sale in Canada.

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: Risk-of thermal harm therapeutic cosmetic energy-based medical devices notice to industry

This guidance document explains the regulatory information requirements and conditions for practitioners and manufacturers when drugs are requested through the …

Record Modified: Dec 29, 2023
Record Released: Dec 27, 2023
Publisher: Health Canada
Formats: HTML
Keywords: special access program SAP drugs guidance document industry practitioners