Health Canada
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Drugs and Health Products
Announcements
- Guidance for Clinical Trial Sponsors: Clinical Trial Applications [2013-06-21]
- Electronic Specifications for Clinical Trial Applications and Amendments filed in accordance with Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications [2013-06-21]
- Updated - Notice - New requirements for submitting administrative drug submissions to Health Canada [2013-04-29]
- Publication of information about certain Clinical Trial Applications authorized by Health Canada [2013-04-26]
- Notice - Content changes to Notices of Compliance issued for administrative submissions [2013-03-19]
- Notice - Regulatory Cooperation Council (RCC) Over-the-Counter (OTC) Products - Common Monograph Working Group - Selection of a Monograph for Alignment [2013-01-10]
- Notice - Updated Screening Criteria for Generic Drug Submissions [2013-01-09]
- Notice - Annual Drug Notification package is now being sent electronically [2012-07-31]
- Notice - 2012 Annual Drug Notification and Fee Remission Request [2012-07-31]
- Summary Basis of Decision Phase II: Launch Notice [2012-06-29]
- Instructions for the Completion of the Annual drug Notification Form - Human and Veterinary Drugs [2012-06-12]
- Fact sheet on Drug Shortages [2012-06-08]
- Notice: Categorization of Therapeutic Products at the Device / Drug Interface [2012-05-31]
- Notice - Revisions made to guidance documents and forms for drugs and medical devices to show the annual 2% increase in fees [2012-04-02]
- Notice - Clarification to brand name changes being made following the Guidance Document: Fees for the Review of Drug Submissions and Applications [2011-10-27]
- Notice - Health Canada would like to remind sponsors not to include credit card, wire, or cheque payment information within electronic submissions [2011-05-19]
- Notice Regarding Interim Approach for Evaluating Cardiovascular Risk for New Antidiabetic Therapies to Treat Type 2 Diabetes Mellitus [2011-04-27]
- Notice - Instructions for Submitting Drug Notification Forms (DNF) and Supporting Documents in Electronic Format [2010-12-03]
- Notice - Good Laboratory Practice (GLP) Recognition for Canadian Facilities: Reminder to schedule your inspection before the end of the transition period [2010-09-30]
- Notice - Acetonitrile Shortage Pertaining to Pharmaceutical Procedures [2010-08-20]
- Notice - Revisions to the Clinical Trial Application Guidance Documents for Clinical Trial Sponsors [2010-06-28]
- Notice - Revision of the Procedure on the issuance of Drug Identification Numbers (DINs) for Unit Dose Pre-filled Syringes [2010-06-10]
- Notice - Release of a new version of the Drug Product Database Online Query [2010-04-01]
- Submissions Containing Clinical Data from Studies Conducted outside of Canada [2009-06-16]
- Notice: To Market Authorization Holders: Health Canada's Decision on Labelling of Certain Paediatric (0 to under 12 years) Nonprescription Cough and Cold Products in Canada [2008-12-18]
- Notice - 1st Canadian Workshop on Recent Issues in GLP Bioanalysis [2008-01-09]
- Notice - Integrated Review of Abbreviated New Drug Submissions (ANDSs) [2007-09-26]
- Notice: Category IV / Labelling Standards Submission Application Process Review [2006-12-19]
- Notice: Health Canada selects LORENZ docuBridge for E-Review [2006-06-16]
- Health Canada International Symposium on Drug, Food and Natural Health Product Interactions - Speaker Profiles and Abstracts [2006-02-02]
- Health Canada International Symposium on Drug, Food and Natural Health Product Interactions - Agenda [2006-02-02]
- Notice: Appeals Procedures for Drug Submissions Policy [2005-12-23]
- Health Canada International Symposium on Drug, Food and Natural Health Product Interactions [2005-12-08]
- Health Canada International Symposium on Food, Nutrient, Natural Health Product (NHP) - Drug Interactions [2005-10-03]
- Evaluation of the Regulatory Status for Certain Medicinal Ingredients [2004-07-09]
- Letter of Interest for an E-Submission and E-Review Solution [2004-02-05]
- Call for Volunteers Members for a Working Group on Electronic Submissions [2003-12-23]
- Patient Package Insert [1999-07-21]
