This notice defines the electronic file requirements and provides guidance on the structure, content, and format of electronic information to be included with submissions in the CTD format. Full document...

Health Canada has initiated a formal process to release an updated version of the draft guidance document Guidance for Sponsors of Clinical Trial Applications – Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications and revised Quality Overall Summary – Chemical Entities (Clinical Trial Applications templates). Full document...

Health Canada is pleased to announce a revision to the criteria in Appendix F, "Pilot Implementation of the Hybrid Filing Format," Draft Guidance for Industry: Preparation of Drug Submissions in eCTD Format. Full document...

The Canadian Food Inspection Agency (CFIA) is proposing amendments to the Health of Animals Regulations to remove the provision to issue permits for edible residual material (ERM), effectively banning the feeding of ERM to swine and poultry.

In accordance with the Therapeutic Products Directorate policy entitled please pharmaceutical forms and strengths within a product line may be combined onto one form (e.g. Product X Tablets (25, 50 mg) and Capsules (50 mg)). Full document...

The Health Canada document PHARMACEUTICAL SCIENCES - QUESTIONS AND ANSWERS is intended to provide clarification on a number of issues that relate to Quality (e.g., Chemistry and Manufacturing) and Biopharmaceutics (e.g., Bioequivalence/Bioavailability) information of human drug submissions for pharmaceutical-type products. Full document...

Between January 20 and 22, 2007, a bull on a commercial beef farm in northern Alberta died after having experienced a loss of body condition over the course of the winter. Full document...