Vol. 147, No. 8 — April 10, 2013

Registration

SOR/2013-56 March 21, 2013

FOOD AND DRUGS ACT

Regulations Amending the Food and Drug Regulations (1733 — Clinical Trials — Miscellaneous Program)

P.C. 2013-315 March 21, 2013

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) (see footnote a) of the Food and Drugs Act (see footnote b), makes the annexed Regulations Amending the Food and Drug Regulations (1733 — Clinical Trials — Miscellaneous Program).

REGULATIONS AMENDING THE FOOD AND DRUG REGULATIONS (1733 — CLINICAL TRIALS — MISCELLANEOUS PROGRAM)

AMENDMENT

1. The portion of the definition “chercheur qualifié” in the French version of section C.05.001 of the Food and Drug Regulations (see footnote 1) before paragraph (a) is replaced by the following:

« chercheur qualifié » La personne qui est responsable auprès du promoteur de la conduite de l’essai clinique à un lieu d’essai clinique, qui est habilitée à dispenser des soins de santé en vertu des lois de la province où ce lieu d’essai clinique est situé et qui est :

COMING INTO FORCE

2. These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not of the Regulations.)

Issue and objectives

This miscellaneous amendment makes one correction to the French text in Division 5 of Part C of the Food and Drug Regulations— Drugs for Clinical Trials Involving Human Subjects. The corrective change is necessary to address a discrepancy between the English and French wording of the definition of “qualified investigator” (“chercheur qualifié”) in section C.05.001 of Division 5 of Part C of the Regulations, as per the request of the Standing Joint Committee for the Scrutiny of Regulations (SJCSR).

The change contained in this miscellaneous amendment is to amend the French definition of “qualified investigator” (“chercheur qualifié”) used in Division 5 of Part C of the Regulations.

Description and rationale

Division 5 of Part C of the Regulations applies to the sale or importation of drugs to be used for the purposes of clinical trials involving human subjects.

This miscellaneous amendment makes a correction to Division 5 of Part C of the Regulations in response to a recommendation of the SJCSR. A discrepancy between the English and French wording of the definition of “qualified investigator” (“chercheur qualifié”) in section C.05.001 was inadvertently introduced in SOR/2012-16, a previous amendment to the Regulations that made corrective changes to Division 5 of Part C. Following the publication of SOR/2012-16 in the Canada Gazette, Part II, the SJCSR noted that the French version of the definition of “qualified investigator” (“chercheur qualifié”) was amended by replacing the reference to “soins de santé” with “soins médicaux.” As a result of this change, the definitions of “qualified investigator” and “chercheur qualifié” were rendered discrepant as the English version refers to “health care” while the French refers to “medical care.”

Consultation

The miscellaneous amendment to Division 5 of Part C of the Regulations is an administrative change; therefore, no consultation was conducted.

Implementation, enforcement and service standards

This miscellaneous amendment will be implemented by notifying the general public through publication in the Canada Gazette, Part II, and by notifying both internal and external stakeholders via email of this publication.

This miscellaneous amendment does not alter existing compliance mechanisms under the provisions of the Food and Drugs Act and the Food and Drug Regulations enforced by the Health Products and Food Branch Inspectorate.

Contact

Refer to Project Number: 1733
Policy Division
Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Canada
Holland Cross, Tower B, 2nd Floor
1600 Scott Street
Address Locator: 3102C5
Ottawa, Ontario
K1A 0K9
Telephone: 613-948-4623
Fax: 613-941-6458
Email: regaff-affreg@hc-sc.gc.ca