Articles
November 2010
• Regulatory Compliance
Audit - The Opening Meeting
September 2010
• Regulatory Compliance – Security of Records in Clinical Research
August 2010
• Regulatory Essentials – Types of Clinical Trials and Clinical Trial Application (CTA) Process
July 2010
• - Quality-CQI |
Regulatory Update for October 2010
Due to the large number of updates, we are posting the October information as a seperate page, in Adobe format
Canadian Regulatory Update - Updated October 21, 2010
Medical Device
• September 27, 2010
- Drug and Medical Device Recall Listings Updated [2010-09-27]
- Guidance on the Medical Device Inspection Program (GUI-0064) NEW [2010-09-27]
• August 30, 2010
- Drug and Medical Device Recall Listings [2010-08-30](updated)
• August 13, 2010
- Guidance on Risk Classification of Medical Device Observations (GUI-0079) [2010-08-13] (new)
• July 26, 2010
- List of Recognized Standards 2010-07-26
• May 31, 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
• September 27, 2010
- Drug and Medical Device Recall Listings Updated [2010-09-27]
- Good Clinical Practices (GCP) Information Sessions - November 2010 NEW [2010-09-22]
• August 31, 2010
- Drug Submission Fee Application Form [2010-08-31] (updated)
- How to Pay Fees [2010-08-31] (updated)
• 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- Draft Guidance Document – Labelling of Pharmaceutical Drugs for Human Use [2010-07-07]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
Finished Product Specifications Form [2010-09-09]
• August 27, 2010
- Questions and Answers - Natural Health Products Compliance and Enforcement Policy (POL-0044), August 2010 [2010-08-27] (new)
- Annex to the Natural Health Products Compliance and Enforcement Policy for exempt NHPs under the Natural Health Products (Unprocessed Product Licence Applications) Regulations (NHP-UPLAR) (POL-0093) [2010-08-27] (new)
- Natural Health Products Compliance and Enforcement Policy (POL-0044) [2010-08-27] (new)
• August 19, 2010
Management of Product Licence Applications (PLA) for Natural Health Products [2010-08-19]
• August 6, 2010
Exempted Products [2010-08-06]
• August 3, 2010
Status of Applications Quarterly Report - Quarter 1 (Fiscal year 2010-2011) [2010-08-03]
• 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. |
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Drugs and Pharmaceuticals
August 31, 2010
Drug Shortages: Current Drug Shortages: Technetium Tc99m Generators (updated)
Medication Guides (updated)
Postmarket Requirements and Commitments Download File (updated)
August 30, 2010
Guidance for Industry: Individual Product Bioequivalence Recommendations (26 Newly Added Recommendations; 10 Revised Recommendations)
August 26, 2010
Guidance for Industry: Acute Bacterial Skin and Skin Structure Infections: Developing Drugs for Treatment (PDF - 516kb)
August 16, 2010
Medication Guides (updated)
Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies (updated)
Augusts 4, 2010
Guidance for Industry:Comprehensive List of Guidance Documents (PDF - 740KB)
New/Revised Withdrawn List of Guidances for 2010 (PDF - 80KB)
August 3, 2010
Guidance for Industry: Label Comprehension Studies for Nonprescription Drug Products (PDF - 148KB)
Postmarket Requirements and Commitments
August 2, 2010
National Drug Code Database (updated)
July 30, 2010
- Guidance for Industry: Individual Product Bioequivalence Recommendations (updated)
- Guidance For Industry: The Radioactive Drug Research Committee: Human Research Without An Investigational New Drug Application (PDF - 417KB)
July 8, 2010
- FDA To Conduct Inspections Focusing on 21 CFR 11 (Part 11) requirements relating to human drugs
June 4 - An Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions - Statement of Investigator is available |
