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.
Prescription drugs are an increasingly important part of our health care system, helping prevent and cure disease as well as …
Urgent public health needs can occur, for example, during a flu pandemic, situations such as the opioid crisis or a …
Health Canada questions and answers regarding applicability and recognition, acceptance of study data and the Standards Council of Canada
In order to facilitate the implementation of the E3 Guideline, the International Conference on Harmonisation (ICH) Experts have developed a …
Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: E5 …
Q&A Regarding the Adoption of Periodic Benefit Risk Evaluation Report.
Guidance on the regulatory requirements for prescription labelling of opioid drugs.
Health Canada's approach to the registration and disclosure of Canadian clinical trial information
Regulatory Decision Summaries (RDSs) explain Health Canada's decision for certain 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 …