• Resources
  • Blog
  • Journalists
  • Webcasts
  • Data Privacy
  • Français
  • my CNW 
    • Login
    • Register
  • Client Login 
    • Online Member Centre
    • Next Gen Communications Cloud
    • Cision Communications Cloud®
  • Sign Up
  • Send a Release
Cision Canada
  • News
  • Products
    • Overview
    • Cision Communications Cloud®
    • Monitoring
    • Distribution
    • Multimedia
    • Measurement & Analytics
    • IR
  • Contact
    • Become a Client
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • General Enquiries
    • Media

 

When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
Advanced Search
    Advanced Search
  • News in Focus
      • Browse News Releases
      • All News Releases
      • All Public Company


      • News Releases Overview
      • Multimedia Gallery
      • All Multimedia
      • All Photos
      • All Videos


      • Multimedia Gallery Overview
      • Trending Topics
      • All Trending Topics


  • Business
      • Auto & Transportation
      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation


      • Auto & Transportation Overview
      • Business Technology
      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors


      • Business Technology Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Financial Services & Investing
      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Stock Offering
      • Stock Split
      • Venture Capital


      • Financial Services & Investing Overview
      • General Business
      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News


      • General Business Overview
  • Science & Tech
      • Consumer Technology
      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications


      • Consumer Technology Overview
      • Energy & Natural Resources
      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities


      • Energy & Natural Resources Overview
      • Environ­ment
      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters


      • Environ­ment Overview
      • Heavy Industry & Manufacturing
      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco


      • Heavy Industry & Manufacturing Overview
      • Telecomm­unications
      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications


      • Telecomm­unications Overview
  • Lifestyle & Health
      • Consumer Products & Retail
      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys


      • Consumer Products & Retail Overview
      • Entertain­ment & Media
      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television


      • Entertain­ment & Media Overview
      • Health
      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine


      • Health Overview
      • Sports
      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories


      • Sports Overview
      • Travel
      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry


      • Travel Overview
  • Policy & Public Interest
      • Policy & Public Interest
      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Canadian Federal Government
      • Canadian Municipal Government
      • Canadian Provincial Government
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy


      • Policy & Public Interest Overview
  • People & Culture
      • People & Culture
      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women


      • People & Culture Overview
  • Overview
  • Cision Communications Cloud®
  • Monitoring
  • Distribution
  • Multimedia
  • Measurement & Analytics
  • IR
  • Become a Client
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • General Enquiries
  • Media
  • Cision Canada
  • Send a Release
  • FR
    • Phone

    • 877-269-7890 from 8 AM - 10 PM ET

    • ALL CONTACT INFO

      Contact Cision

      877-269-7890
      from 8 AM - 10 PM ET

  • Send a Release
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • Webcasts
  • GDPR
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Business
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Policy & Public Interest
    • Policy & Public Interest
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • People & Culture
    • People & Culture
    • Send a Release
    • Sign Up
    • Log In
    • Resources
    • Blog
    • Journalists
    • RSS
    • GDPR
  • Send a Release
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • Webcasts
  • GDPR
  • Overview
  • Cision Communications Cloud®
  • Monitoring
  • Distribution
  • Multimedia
  • Measurement & Analytics
  • IR
  • Send a Release
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • Webcasts
  • GDPR
  • Become a Client
  • Request a Demo
  • Editorial Bureaus
  • Partnerships
  • General Enquiries
  • Media
  • Worldwide Offices
  • Send a Release
  • Sign Up
  • Resources
  • Blog
  • Journalists
  • Webcasts
  • GDPR

Statement from Health Canada on the publication of a white paper on Public Release of Clinical Information in Drug Submissions and Medical Device Applications Français


News provided by

Health Canada

Mar 09, 2017, 16:47 ET

Share this article


OTTAWA, March 9, 2017 /CNW/ - Health Canada recognizes that access to clinical information can help health researchers and practitioners, improve patient safety and health outcomes for Canadians. To that end, Health Canada is proposing to proactively make certain clinical information from drug submissions and medical device applications publicly available following the completion of its regulatory review process. Once a final decision is reached on a drug submission or medical device application, clinical information would no longer be confidential business information and would be proactively released to the public. The Department has released the white paper Public Release of Clinical Information in Drug Submissions and Medical Device Applications which sets out the policy rationale and proposed approach for future regulatory development that would allow this to happen.

This approach would support Canada's Open Government initiative to create greater transparency and accountability, increase citizen engagement, and drive innovation and economic opportunities through open data, open information, and open dialogue.

Improving access to this information would also make Health Canada more accountable for its decisions and enable closer public scrutiny of researchers' and product sponsors' findings. In addition, Health Canada's approach would be better aligned with the policies of forward-thinking international regulators, including the European Medicines Agency and the US Food and Drugs Administration.

Canadians have 75 days to provide their feedback on the white paper.

Health Canada is also publishing the final guidance document on Disclosure of Confidential Business Information under the Food and Drugs Act.

This guidance applies to Health Canada's existing authority to disclose confidential business information regarding therapeutic products. It would continue to apply to other confidential business information that would not become publicly available as a result of the proposal in the white paper on Public Release of Clinical Information in Drug Submissions and Medical Device Applications.

This guidance document is part of Health Canada's existing Regulatory Transparency and Openness Framework. Through the Framework, Health Canada has committed to providing Canadians greater access to credible, timely and useful information to allow them to make well-informed decisions concerning their health and that of their families.  

Associated Links:

Draft Guidance Document – Disclosure of Confidential Business Information under the Food and Drugs Act

SOURCE Health Canada

For further information: Contacts: Media Relations, Health Canada, (613) 957-2983; Public Inquiries: (613) 957-2991, 1-866 225-0709

Modal title

Organization Profile

Health Canada

    Also from this source

  • Advisory - Hand sanitizers labelled as "Anti-Microbe" and/or with ...

  • Statement of the Federal-Provincial-Territorial Ministers of...

  • COVID-19 Expert Panel provides science-based advice on optimizing ...

Related Organization(s)

Government of Canada

    Also from this source

  • Tax Tip - It's tax time! You've got questions? We've got answers...

  • Government of Canada announces agreement with Government of...

  • Tourism: A key sector in planning Québec and Chaudière-Appalaches ...

    Contact Cision

  • 877-269-7890
    from 8 AM - 10 PM ET

    • Become a Client
    • Request a Demo
    • Editorial Bureaus
    • Partnerships
    • General Enquiries
    • Media
    • Worldwide Offices

    Products

  • Cision Communications Cloud®
  • Media Monitoring
  • Content Distribution
  • Multimedia Distribution
  • Measurement & Analytics
  • Investor Relations

    About

  • About Cision Canada
  • About Cision
  • Media Partners
  • Careers

    My Services

  • All News Releases
  • Online Member Centre
  • Next Gen Communications Cloud
  • Cision Communications Cloud®
  • my CNW

Contact Cision


Products


About


My Services
  • All News Releases
  • Online Member Centre
  • Next Gen Communications Cloud
  • Cision Communications Cloud
  • my CNW
877-269-7890
from 8 AM - 10 PM ET
  • Terms of Use
  • Information Security Policy
  • Site Map
  • Cookie Settings
  • Accessibility Statement
Copyright © 2021 CNW Group Ltd. All Rights Reserved. A Cision company.