Open Government Portal
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 …
This notice applies to energy-based medical devices for therapeutic or cosmetic indications intended for sale in Canada.
This guidance document explains the regulatory information requirements and conditions for practitioners and manufacturers when drugs are requested through the …
The Special Access Programme (SAP) allows practitioners to request access to drugs that are unavailable for sale in Canada. This …
Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance Document: …
E9: Statistical Principles of Clinical Trials. This guidance has been developed by the appropriate ICH Expert Working Group and has …