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Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2019-06-06 and last amended on 2019-05-22. Previous Versions

PART CDrugs (continued)

DIVISION 3 (continued)

Positron-emitting Radiopharmaceuticals (continued)

Additional Information

 If the information submitted under section C.03.307 is insufficient to enable the Minister to determine whether the sale or importation of the study drug should be authorized, the Minister may, by notice in writing, request the sponsor to provide any additional information that is necessary to make the determination and that is relevant to the study drug, the study or the protocol, by the date specified in the notice.

  • SOR/2012-129, s. 5
Authorization

 After examining the application and any additional information, the Minister shall authorize the sponsor to sell or import the study drug if she or he determines that the application complies with the requirements of section C.03.307, and shall send a notice of that decision to the sponsor that specifies the study sites in respect of which the sale or importation are authorized.

  • SOR/2012-129, s. 5
Notice

 The sponsor shall notify the Minister in writing of the day on which the sale or importation of the study drug is intended to start in respect of each study site, not later than 15 days before that day.

  • SOR/2012-129, s. 5
Good Clinical Practices

 A sponsor shall ensure that each study is conducted in accordance with good clinical practices and that

  • (a) the study is scientifically sound and clearly described in its protocol;

  • (b) the study is conducted, and the study drug is used, in accordance with the protocol and with these Regulations;

  • (c) systems and procedures are implemented that assure the quality of every aspect of the study;

  • (d) at each study site, there is only one qualified investigator;

  • (e) at each study site, medical care and medical decisions, in respect of the study, are under the supervision of the qualified investigator;

  • (f) each individual who is involved in the conduct of the study is qualified by their education, training and experience to perform their respective tasks;

  • (g) before a study subject participates in the study, a copy of their signed consent form is included in the records for the study;

  • (h) the requirements respecting information and records set out in section C.03.315 are met; and

  • (i) the study drug is manufactured, handled and stored in accordance with Division 2, other than sections C.02.019, C.02.025 and C.02.026.

  • SOR/2012-129, s. 5
Labelling

 Despite any other provision of these Regulations respecting labelling, the sponsor shall ensure that the study drug

  • (a) bears an inner label that sets out both of the following:

    • (i) the unique batch number for the study drug, and

    • (ii) the radiation warning symbol set out in Schedule 3 to the Radiation Protection Regulations and the words “RAYONNEMENT — DANGER — RADIATION”; and

  • (b) is accompanied by a package insert that sets out all of the following information:

    • (i) a statement that indicates that the study drug is to be used only under the supervision of a qualified investigator,

    • (ii) the chemical or generic name of the active ingredients in the study drug,

    • (iii) the name and civic address of the manufacturer,

    • (iv) the name and civic address of the sponsor,

    • (v) the code or other identification of the protocol,

    • (vi) the warnings and precautions in respect of the use of the study drug, and

    • (vii) a list of the possible adverse reactions that are associated with the use of the study drug.

  • SOR/2012-129, s. 5
  • SOR/2018-69, s. 24(F)
Submission of Information
  •  (1) On the Minister’s written request, a sponsor shall submit, within the period specified in the request, information to establish the safety of the study drug if the Minister has reason to believe any of the following:

    • (a) the use of the study drug may endanger the health of a study subject or other person;

    • (b) the study may be contrary to the best interests of the study subjects;

    • (c) a qualified investigator is not respecting their undertaking made under paragraph C.03.315(3)(f); or

    • (d) information submitted in respect of the study drug or study is false or misleading.

  • (2) The Minister may, by notice in writing, require the sponsor to provide the Minister with any information or records referred to in subsection C.03.315(3) to assess the safety of the study drug or the health of the study subjects or other persons, by the date specified in the notice.

  • SOR/2012-129, s. 5
Adverse Reaction Reporting
  •  (1) During the course of a study, the sponsor shall notify the Minister of any serious adverse reaction or serious unexpected adverse reaction that occurs inside or outside Canada, within the following period:

    • (a) if the adverse reaction is fatal or life-threatening, within seven days after becoming aware of it; or

    • (b) if the adverse reaction is not fatal or life-threatening, within 15 days after becoming aware of it.

  • (2) The sponsor shall, within eight days after having notified the Minister under subsection (1), file with the Minister a complete report in respect of the adverse reaction, including an assessment of the importance and implication of the findings.

  • (3) Sections C.01.016 to C.01.020 do not apply to study drugs.

  • SOR/2012-129, s. 5
Records
  •  (1) The sponsor shall record, handle and store all information in respect of a study in a way that allows it to be reported completely and accurately and to be interpreted and verified.

  • (2) The sponsor shall maintain complete and accurate records to establish that the study is conducted in accordance with these Regulations.

  • (3) The sponsor shall maintain all of the following records in respect of the use of the study drug in each study:

    • (a) records respecting all adverse reactions that occur inside or outside Canada, including the indications for use and the dosage form of the study drug at the time of the adverse reaction;

    • (b) written procedures for subject monitoring and for the documentation and reporting of adverse reactions;

    • (c) articles from scientific journals or other publications that were used in support of the safety profile of the study drug in respect of humans;

    • (d) records in respect of each study subject, including respecting their enrolment, a copy of their signed consent form and sufficient information to enable them to be identified and contacted in the event that the sale of the study drug may endanger their health or that of another person;

    • (e) records respecting the shipment, receipt, sale, return and destruction or other disposition of the study drug;

    • (f) for each study site, an undertaking, dated and signed by the qualified investigator before the start of the study, that they will

      • (i) conduct the study in accordance with good clinical practices, and

      • (ii) on discontinuance of the study by the sponsor, for any reason related to health or safety, immediately inform both the study subjects and the research ethics board of the discontinuance, provide them with the reasons for the discontinuance and advise them in writing of any potential risks to the health of study subjects or other persons;

    • (g) for each study site, a copy of the informed consent form; and

    • (h) for each study site, a copy of the certifying statement described in paragraph C.03.307(2)(q), of the protocol for the study and of the statement of the risks and anticipated benefits arising to the health of study subjects as a result of participating in the study that is set out in the informed consent form.

  • (4) The sponsor shall maintain all records for five years after the day on which the study ends.

  • SOR/2012-129, s. 5
Discontinuance of a Study
  •  (1) If a sponsor discontinues a study in its entirety or at a study site, the sponsor shall notify all qualified investigators of the discontinuance as soon as possible in writing, and include in the notice the reasons for the discontinuance and whether the study presented any risks to the health of study subjects or other persons.

  • (2) If the discontinuance is for reasons that would affect the health or safety of study subjects or other persons, the sponsor shall notify the Minister in writing within 15 days after the discontinuance, and include in the notice the reasons for the discontinuance and whether it will have an impact on any proposed or ongoing studies in respect of the study drug in Canada by the sponsor.

  • SOR/2012-129, s. 5
 
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