Canada Gazette, Part I, Volume 159, Number 51: Regulations Amending Certain Regulations Relating to Clinical Trials

December 20, 2025

Statutory authorities
Food and Drugs Act
Patent Act
Tobacco and Vaping Products Act
Cannabis Act

Sponsoring department
Department of Health

REGULATORY IMPACT ANALYSIS STATEMENT

For the Regulatory Impact Analysis Statement, see the Clinical Trials Regulations.

PROPOSED REGULATORY TEXT

Notice is given that the Governor in Council proposes to make the annexed Regulations Amending Certain Regulations Relating to Clinical Trials under section 30footnote a of the Food and Drugs Act footnote b, subsections 101(1)footnote c and 134(1)footnote d of the Patent Act footnote e, subsection 42.2(1)footnote f of the Tobacco and Vaping Products Act footnote g and subsection 139(1) of the Cannabis Act footnote h.

Interested persons may make representations concerning the proposed Regulations within 90 days after the date of publication of this notice. They are strongly encouraged to use the online commenting feature that is available on the Canada Gazette website but if they use email, mail or any other means, the representations should cite the Canada Gazette, Part I, and the date of publication of this notice, and be sent to Debra Haltrecht, Acting Executive Director, Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Department of Health, Address Locator: 3001, 11 Holland Avenue, Suite P2108, Ottawa, Ontario K1A 0K9 (email: lrm.consultations-mlr@hc-sc.gc.ca).

Ottawa, December 15, 2025

Janna Rinaldi
Acting Assistant Clerk of the Privy Council

Regulations Amending Certain Regulations Relating to Clinical Trials

Food and Drugs Act

Food and Drug Regulations

1 Subparagraph C.01.020.1(3)(b)(ii) of the Food and Drug Regulations footnote 1 is replaced the following:

2 Paragraph C.01A.002(1)(c) of the Regulations is replaced by the following:

3 Subsection C.03.302(2) of the Regulations is replaced by the following:

(2) Sections C.03.001 to C.03.209 and Division 8 do not apply to study drugs.

(2.1) The Clinical Trials Regulations do not apply to

4 Division 5 of Part C of the Regulations is repealed.

5 Subsection C.08.006(1) of the Regulations is replaced by the following:

C.08.006 (1) For the purposes of subsection (2), evidence or new information obtained by the Minister includes any information or material filed by any person under

6 Subsection C.08.009.1(1) of the Regulations is replaced by the following:

C.08.009.1 (1) In sections C.08.009.2 and C.08.009.3, information in respect of a clinical trial means information — in respect of a clinical trial involving a drug — that is contained in a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission for a new drug for human use filed under section C.08.002, C.08.002.01 or C.08.002.1 or in a supplement to any of those submissions filed under section C.08.003.

Natural Health Products Regulations

7 The Natural Health Products Regulations footnote 2 are amended by adding the following after section 64:

64.1 The Clinical Trials Regulations do not apply to

8 Section 110 of the Regulations is repealed.

Cannabis Exemption (Food and Drugs Act) Regulations

9 Paragraph 1(f) of the Cannabis Exemption (Food and Drugs Act) Regulations footnote 3 is replaced by the following:

Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations

10 The title of the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations footnote 4 is replaced by the following:

Clinical Trials for Medical Devices Relating to COVID-19 Regulations

11 The definitions COVID-19 drug and COVID-19 drug authorization in section 1 of the Regulations are repealed.

12 The definition research ethics board in section 1 of the Regulations is replaced by the following:

research ethics board
means a body that is not affiliated with an applicant for a COVID-19 medical device authorization, or a holder of such an authorization, and whose principal mandate is to approve the initiation of, and conduct periodic reviews of, biomedical research involving human subjects in order to ensure the protection of their rights, safety and well-being. (comité d’éthique de la recherche)

13 Subsection 2(1) of the Regulations is replaced by the following:

Words and expressions

2 (1) Unless the context otherwise requires, words and expressions used in these Regulations have the same meaning as in the Medical Devices Regulations.

14 (1) Subsection 3(1) of the Regulations is replaced by the following:

Application

3 (1) These Regulations apply to the importation and sale of a COVID-19 medical device, other than a Class I device, that is to be tested in a clinical trial and to the conduct of a clinical trial in respect of such a device.

(2) Subsection 3(3) of the Regulations is repealed.

15 Part 2 of the Regulations is repealed.

16 Subsection 36(1) of the Regulations is replaced by the following:

Remote written informed consent

36 (1) If a qualified investigator is not able to obtain, in person, the written informed consent of a person to participate in a clinical trial in respect of a COVID-19 medical device for which a COVID-19 medical device authorization has been issued, the qualified investigator may obtain the written informed consent remotely.

17 Section 37 of the Regulations is repealed.

18 Section 38 of the Regulations is amended by adding the following after subsection (2):

Words and expressions

(3) Unless the context otherwise requires, words and expressions used in this section have the same meaning as in the Food and Drug Regulations.

19 (1) Paragraph 41(1)(a) of the Regulations is replaced by the following:

(2) Subparagraph 41(1)(b)(i) of the Regulations is replaced by the following:

(3) Paragraph 41(3)(a) of the Regulations is replaced by the following:

(4) Clause 41(3)(b)(i)(A) of the Regulations is replaced by the following:

(A) section C.03.319 of the Food and Drug Regulations, or

Patent Act

Patented Medicines Regulations

20 Subsection 5(3) of the Patented Medicines Regulations footnote 5 is amended by adding the following after paragraph (a):

Certificate of Supplementary Protection Regulations

21 Subsection 1(2) of the Certificate of Supplementary Protection Regulations footnote 6 is replaced by the following:

Definition of authorization for sale

(2) In these Regulations and for the purposes of section 104 of the Act, authorization for sale means an authorization under the Food and Drugs Act, or any predecessor enactment relating to the same subject matter, that permits the sale of a drug in Canada, but does not include

Tobacco and Vaping Products Act

Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act

22 (1) Paragraph 2(c) of the Regulations Excluding Certain Vaping Products Regulated Under the Food and Drugs Act from the Application of the Tobacco and Vaping Products Act footnote 7 is replaced by the following:

(2) Section 2 of the Regulations is amended by striking out “and” at the end of paragraph (g), by adding “or” at the end of paragraph (h) and by adding the following after paragraph (h):

Cannabis Act

Cannabis Regulations

23 (1) The portion of the definition drug in subsection 1(2) of the Cannabis Regulations footnote 8 after subparagraph (b)(ii) is replaced by the following:

It includes cannabis that is an active pharmaceutical ingredient as defined in subsection C.01A.001(1) of the Food and Drug Regulations. It also includes cannabis that is manufactured or sold for use in a clinical trial, as defined in section 2 of the Food and Drugs Act, that is not non-therapeutic research on cannabis. (drogue)

(2) The portion of the definition non-therapeutic research on cannabis in subsection 1(2) of the Regulations before paragraph (a) is replaced by the following:

non-therapeutic research on cannabis
means research that involves the distribution of cannabis to human participants by the holder of a licence for research and that is not a clinical trial, as defined in section 2 of the Food and Drugs Act, for which the sale of cannabis is authorized under subsection 8(1) of the Clinical Trials Regulations or in respect of which the sponsor, as defined in subsection 1(1) of those Regulations, is exempt from section 3.1 of that Act under subsection 6(1) of those Regulations. This definition does not include research

Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages

24 Subsection 28(2) of the Regulations Amending Certain Regulations Concerning Cannabis Research and Testing and Cannabis Beverages footnote 9 is replaced by the following:

Definition of research with human participants

(2) For the purposes of subsection (1), research with human participants means research that involves the distribution of cannabis to human participants and that is not a clinical trial, as defined in section 2 of the Food and Drugs Act,

Coming into Force

25 These Regulations come into force on the day on which the Clinical Trials Regulations come into force.

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