G/TBT/N/CAN/536  
 
14 December 2017  
(17-6947) Page: 1/2 
Committee on Technical Barriers to Trade  Original: English/French  
 
  
NOTIFICATION  
The following notification is being circulated in accordance with Article 10.6  
 
1. Notifying Member: CANADA   
If applicable, name of local government involved (Article 3.2 and 7.2):   
2. Agency responsible: Department of Health  
Name and address (including telephone and fax numbers, email and website 
addresses, if available) of agency or authority designated to handle comments 
regarding the notification shall be indicated if different from above:   
Canada 's Notification Authority and Enquiry Point  
Global Affairs Canada  
Technical Barriers and Regulations Division  
111 Sussex Drive, Ottawa, ON K1A 0G2  
Canada  
Telephone: (343) 203 -4273 
Fax: (613) 943 -0346 
E-mail: enquirypoint@international.gc.ca  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], other:  
4. Products covered (HS or CCCN where applicable, otherwise national tariff 
heading. ICS numbers may be provided in addition, where applicable): Drugs and 
Medical Devices (ICS: 11.120; 11.040)  
5. Title, number of pages and language(s) of the notified documen t: Regulations 
Amending the Food and Drug Regulations (Public Relea se of Clinical Information) 
(16 pages, in English and French)   
6. Description of content: In 2014, the Protecting Canadians from Unsafe Drugs Act  
amended  the Food and Drugs Act  regarding d rugs and medical devices in order to 
improve safety by introducing measures to, among other things:  
1. strengthen safety oversight of therapeutic products throughout their lifecycle;  
2. improve reporting by certain health care institutions of serious adverse drug 
reactions and medical device incidents that involve therapeutic products; and  
3. promote greater confidence in the oversight of therapeutic products by increasing 
transparency.  
Most information related to clinical trials that is submitted to Health Canad a in drug 
submissions and medical device applications has typically been treated as confidential 
business information (CBI).  This information is used to assess the safety and efficacy of a 
drug in humans, and the safety and effectiveness of medical devices . 
In order to promote greater confidence in the regulatory oversight of drugs and medical 
devices new transparency -related regulation -making authorities brought in 2014 permit 
the Governor in Council to make regulations that specify that certain informatio n obtained 
under the Act that is not Confidential Business Information (CBI) or the circumstances in 
which it ceases to be CBI.  The regulation -making authorities also permit the making of 
regulations that allow the release of this information.   G/TBT/N/CAN/536  
 
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  7. Objecti ve and rationale, including the nature of urgent problems where 
applicable: The objective of this proposal is to provide public access to clinical information 
submitted to Health Canada in drug submissions for human use and medical device 
applications foll owing a final regulatory decision.   
8. Relevant documents:  Canada Gazette , Part I, 9 December  2017, pages 4637 - 4653 
(available in English and French).   
Additional and background information on the proposal for public release of clinical 
information is available from the following web sites, in English and French:  
https://www.canada.ca/en/health -canada/prog rams/public -release -clinical -information -
drug-submissions -medical -device -applications.html  
https://www.canada.ca/fr/sante -canada/programmes/diffusion -publique -renseig nements -
cliniques -presentations -medicaments -demandes -homologation -instruments -medicaux.html   
9. Proposed date of adoption:  Not stated  
Proposed date of entry into force:  These regulations will come into force on the day 
they are published in Canada Gazette  Part II.  
10. Final date for comments: 22 February 2018  
11. Texts available from: National enquiry point [X] or address, telephone and fax 
numbers and email and website addresses, if available, of other body:   
The electronic version of the regulatory text is available from the following web sites, in 
English and French:  
http://gazette.gc.ca/rp -pr/p1/2017/2017 -12-09/html/reg3 -eng.php  
http://gazette.gc.ca/rp -pr/p1/2017/2017 -12-09/html/reg3 -fra.php