Articles
August 2010
• Regulatory Essentials – Types of Clinical Trials and Clinical Trial Application (CTA) Process
July 2010
• - Quality-CQI |
Canadian Regulatory Update - Updated August 5, 2010
Medical Device
• July 26, 2010
- List of Recognized Standards 2010-07-26
• May 313, 2010
- Adoption of Global Harmonization Task Force (GHTF) Guidance: Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers [2010-05-31]
Drugs and Pharmaceuticals
• July 23, 2010
- Register of Innovative Drugs [2010-07-23]
• July 15, 2010
- Upcoming launch of the updated version of the Notice of Compliance (NOC) Online Database and the addition of Weekly Data Extracts which will replace the current NOC Listings 2010-07-16]
- Register of Innovative Drugs [2010-07-15]
• July 7, 2010
- Draft Guidance Document – Labelling of Pharmaceutical Drugs for Human Use [2010-07-07]
• June 30, 2010
- TPD Annual Report 2007-2008 [2010-06-30]
• June 28, 2010
- Notice - Revisions to the Clinical Trial Application Guidance Documents for Clinical Trial Sponsors [2010-06-28]
Natural Health Products
• July 21, 2010
- Natural Health Products Directorate Electronic Subscriber Service [2010-07-21]
• July 13, 2010
- Read the Label - Natural Health Products [2010-07-13]
June 24 - Health Canada has issued a Notice on Policy 0019 and the Guidance Document on the Commercial Importation and Exportation of Drugs in Dosage Form under the food and Drug Act (GUIDE 0057)
June 17 - Health Canada has issued a Notice their intention to adopt the use of the summary technical document (STED) for non-in vitro diagnostic Class III and IV pre-market medical device licence applications. This affects all manufacturers of non-in vitro diagnostic Class III and IV medical devices.
June 10, 2010 - A new guidance document ‘Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats’, is now available. |
