G/TBT/N/CAN/685  
21 December 2022  
(22-9621)  Page: 1/3 
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 Auth ority and 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@international.gc.ca  
3. Notified under Article 2.9.2 [X], 2.10.1 [  ], 5.6.2 [  ], 5.7.1 [  ], 3.2 [  ], 7.2 [  ], 
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 codes: 11.120, 11.040)  
5. Title, number of pages and language(s) of the notified document:  Regulations 
Amending Certain Regulations made under the Food and Drugs Act (Agile Licensing); (93 
page(s), in English), (93 page(s), in French)  
6. Description of content:  Health Canada is proposing new targeted provisions and 
regulatory amendments to the Food and Drug Regulations and Medical Devices 
Regulations  that would deliver on the Department's modernization commitments and 
leverage long -standing policies and practices. The proposal would take into account recent 
experience with regulatory agilities successfully piloted through t he COVID -19 interim 
orders and their transition to regulations. This proposal is comprised of distinct 
components that would:  
• Enable the use of terms and conditions on the drug identification number of any 
drug;  
• Broaden the scope of use of terms and condit ions for Class II, III, and IV medical 
devices;  
• Require risk management plans for certain human drugs to manage risks and 
uncertainties;  G/TBT/N/CAN/685  
 
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  • Allow for the option of a rolling review for certain drug submissions, including 
those for drugs intended to address a public health emergency;  
• Extend modified requirements and prepositioning that apply to COVID -19 drugs 
to other drugs needed to address future public health emergencies;  
• Clarify expectations that a drug be fabricated, packaged/labelled, tested and 
stored, i ncluding during transportation, in a manner that assures its quality;  
• Modernize requirements for biologics by repealing outdated requirements and 
replacing them with those that reflect current practices;  
• Clarify, in regulation, the authority to consider certain information obtained 
outside of a new drug submission to support Health Canada's examination of that 
submission for a new drug;  
• Require manufacturers to submit human clinical trial data broken down by 
population sub -groups (disaggregated d ata) for new and supplemental human 
drug submissions, as submitted to the United States Food and Drug 
Administration or the European Medicines Agency; and  
• Update requirements respecting standards for labelling and requirements for 
those that claim a manufa cturer's standard for their drug.  
7. Objective and rationale, including the nature of urgent problems where 
applicable:  The objective of this proposal is to contribute to the modernization of the 
Canadian therapeutic product regulatory system.  
The amendme nts would:  
• enable the Minister of Health to better manage risks and uncertainties for a drug 
or medical device that is authorized for sale;  
• facilitate earlier market access for certain drugs, including public health 
emergency drugs;  
• provide clarity to industry and the regulator respecting quality control rules and 
expectations under good manufacturing processes as well as the types of 
information and material that may be considered by the Minister in support of the 
review of a drug submission;  
• replace p roduct -specific requirements for biologics with broader, more flexible 
regulations that would better address advancements in science and technology;  
• provide Health Canada with disaggregated data to evaluate the safety and 
effectiveness of drugs within dive rse subpopulations; and  
• address long standing concerns from industry respecting labeling of the standard 
and requirements for certain drugs that claim a manufacturer's standard.  
8. Relevant documents:   
Canada Gazette , Part I, December 17, 2022, pages 6058 -6150, 
https://canadagazette.gc.ca/rp -pr/p1/2022/2022 -12-17/pdf/g1 -15651.pdf#page=38  
(available in English and French)  
Proposed Guidance Documents:  
Consultat ion on proposed agile regulations and guidance for licensing drugs and medical 
devices: https://www.canada .ca/en/health -canada/programs/consultation -proposed -
agile-regulations -guidance -licensing -drugs -medical -devices.html  (English)  
Consultation sur le projet de règlement agile et des lignes directrices pour l'homologation 
des médicaments et des instruments méd icaux : https://www.canada.ca/fr/sante -
canada/programmes/consultation -projet -reglementation -souple -lignes -directrices -
homologation -medicaments -instruments -medicaux.html  (French)  G/TBT/N/CAN/685  
 
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  9. Proposed date of adoption:  To be determined  
Proposed date of entry into force:  The proposed regulatory amendments would come 
into force in accordance with the following:  
Immediate coming into force (upon registration, date of adoption):  
• Amendments related to public health emergency drugs (including terms and conditions, 
rolling reviews and pre -positioning);  
• Assuring drug quality during manufacturing;  
• Modernizing requirements for biologic drugs;  
• Information considered to support the examination of drug submissio ns; 
• Disaggregated clinical trial data for new human drug submissions and supplemental new 
human drug submissions; and  
• Standards.  
Delayed coming into force (one year following registration):  
• Terms and conditions (for all drugs and for Class II, III an d IV medical devices);  
• Risk management plans; and  
• Rolling reviews (for drugs other than public health emergency drugs).  
At a time set out in a future regulatory amendment once the Department determines that 
provisions specific to COVID -19 are no longer  required:  
• Amending the definition of public health emergency drug to no longer include a new 
drug for which the purpose or conditions of use recommended by the  manufacturer relate 
to COVID -19; and  
• Removing other COVID -19-specific provisions.  
10. Final date for comments:  27 March 2023  
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://canadagazette.gc.ca/rp -pr/p1/2022/2022 -12-17/html/reg1 -eng.html  (English)  
https://canadagazette.gc.ca/rp -pr/p1/2022/2022 -12-17/html/reg1 -fra.html  (French)