  
  
G/TBT/N/CAN/665  
7 March 2022  
(22-2049) 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:  Health Canada  
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 a nd Enquiry Point  
Technical Barriers and Regulations Division  
Global Affairs Canada  
111 Sussex Drive  
Ottawa, Ontario, K1A 0G2  
Canada  
Telephone: (343)203 -4273 
Fax: (613)943 -0346 
Email: enquirypoint@int ernational.gc.ca  
3. Notified under Article 2.9.2 [   ], 2.10.1 [X], 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  
5. Title, number of pages and language(s) of the notified document:  Clinical Trials 
for Medical Devices and Drugs Relating to COVID -19 Regulations (55 pages, available in 
English and French)  
6. Description of content:  In order to address the immediate COVID -19 public health 
emergency, the Minister of Health made the Interim Order Respecting Clinical Trials for 
Medical Devices and Drugs in Relation to COVID -19 (IO No. 1) on 23 May 2020 to put in 
place a more flexible clinical tri als pathway for COVID -19 drugs and medical devices. A 
second Interim Order (IO No. 2) replaced IO No. 1 on 3 May 2021, and transitional 
provisions carried clinical trials authorized under IO No. 1 into IO No. 2. As interim orders 
are temporary, the provisi ons of IO No. 2 were transitioned into regulations to ensure 
that the Interim Order's authorizations, obligations, and oversight continue uninterrupted 
for trials already authorized. The authorization pathway also remains available for new 
clinical trials for drugs and medical devices related to the diagnosis, treatment, mitigation, 
or prevention of COVID -19 given the ongoing and unpredictable nature of the COVID -19 
pandemic.  
In addition, the Regulations contain technical provisions to maintain the status quo for 
clinical trials authorized under the Food and Drug Regulations , Medical Devices 
Regulations  and Natural Health Products Regulations  on or after 23 May 2020.  
At the same time, amendments have been made to the Food and Drug Regulations  and 
the Natural Health Products Regulations  to reduce the records retention period for clinical G/TBT/N/CAN/665  
 
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  trials of drugs and natural health products from 25 to 15 years. This shorter reten tion 
period is expected to reduce the cost and administrative burden on clinical trials 
investigators and sponsors, improve alignment with Canada's international partners and 
contribute to making Canada a more favourable environment for conducting clinical  trials.  
The Regulations also make a consequential amendment to the Certificate of 
Supplementary Protection Regulations to ensure that a clinical trial authorization or 
amendment under the Regulations has no impact on Health Canada's grant of a certificat e 
of supplementary protection (which can provide up to two years of patent -like protection) 
under the Patent Act.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objectives of the Regulations are to:  
• maintain the  provisions of the Interim Orders to ensure that clinical trials for 
COVID -19 drugs and medical devices authorized under the Interim Orders, and 
clinical trials authorized under the existing frameworks in the  Medical Device 
Regulations , the Food and Drugs  Regulations  and Natural Health Product 
Regulations   on or after 23 May 2020, can continue without disruption; and  
• reduce the burden associated with the 25 -year records retention period for 
drugs and natural health products.   
Other  
8. Relevant documents:   
Canada Gazette , Part II, 2 March 2022, pages 548 to 602, https://gazette.gc.ca/rp -
pr/p2/2022/2022 -03-02/pdf/g2 -15605.pdf  (available in English and French)  
Guidance on applications for  COVID -19 drug clinical trials under the Regulations 
: https://www.canada.c a/en/health -canada/services/drugs -health -products/drug -
products/applications -submissions/guidance -documents/clinical -trials/covid -19-
regulations.html  
Guidance on applications for  COVID -19 medical device clinical trials under the Regulations 
: https://www.canada.ca/en/health -canada/services/drugs -health -products/medical -
devices/application -information/guidance -documents/covid -19-clinical -trials.html  
9. Proposed date of adoption:  On the date the amendments were regis tered, which was 
on 11 February 2022.  
Proposed date of entry into force:  Most provisions came into force on 27 February 
2022, which was the day following the day on which the Interim Order No. 2 Respecting 
Clinical Trials for Medical Devices and Drugs Relating to COVID -19 ceased to have effect, 
while some provisions, including the amendments to the Food and Drugs Regulations and 
Natural Health Products Regulations, came into force upon registration.  
10. Final date for comments:  Not applicable (These re gulations have been granted an 
exemption from publication in Canada Gazette, Part I, and therefore a pre -consultation 
was not conducted).  
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 can be found at:  
https://gazette.gc.ca/rp -pr/p2/2022/2022 -03-02/html/sor -dors18 -eng.html  
https://gazette.gc.ca/rp -pr/p2/2022/2022 -03-02/html/sor -dors18 -fra.html  
 