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

Regulations are current to 2022-09-22 and last amended on 2022-07-21. Previous Versions

PART CDrugs (continued)

DIVISION 8 (continued)

New Drugs (continued)

  •  (1) Subject to subsection (1.1) and notwithstanding sections C.08.002 and C.08.003, a manufacturer of a new drug may sell it to a qualified investigator to be used solely for the purpose of clinical testing to obtain evidence with respect to the safety, dosage and effectiveness of that new drug, when the following conditions are met:

    • (a) before the sale, the manufacturer has filed with the Minister, in compliance with section C.08.005.1, a preclinical submission containing information and material respecting

      • (i) the brand name of the new drug or the identifying name or code proposed for the new drug,

      • (ii) the chemical structure or other specific identification of the composition of the new drug,

      • (iii) the source of the new drug,

      • (iv) a detailed protocol of the clinical testing,

      • (v) the results of investigations made to support the clinical use of the new drug,

      • (vi) the contra-indications and precautions known in respect of the new drug and the suggested treatment of overdosage of the new drug,

      • (vii) all ingredients of the new drug, stated quantitatively,

      • (viii) the methods, equipment, plant and controls used in the manufacture, processing and packaging of the new drug,

      • (ix) the tests applied to control the potency, purity and safety of the new drug, and

      • (x) the names and qualifications of all investigators to whom the drug is to be sold and the names of all institutions in which the clinical testing is to be carried out;

    • (b) the Minister has not, within 60 days after the date of receipt of the preclinical submission, sent by registered mail to the manufacturer a notice in respect of that new drug indicating that the preclinical submission is not satisfactory;

    • (c) all inner labels and outer labels used in conjunction with the sale of the new drug to qualified investigators carry the statements

      • (i) “Investigational Drug” or “Drogue de recherche”, and

      • (ii) “To Be Used By Qualified Investigators Only” or “Réservée uniquement à l’usage de chercheurs compétents”;

    • (d) before the sale, the manufacturer ascertains that every qualified investigator to whom the new drug is to be sold

      • (i) has the facilities for the clinical testing to be conducted by the investigator, and

      • (ii) has received the information and material referred to in subparagraphs (a)(i) to (vi); and

    • (e) every qualified investigator to whom the new drug is to be sold has agreed in writing with the manufacturer that the investigator will

      • (i) not use the new drug or permit it to be used other than for clinical testing,

      • (ii) not permit the new drug to be used by any person other than the investigator except under the investigator’s direction,

      • (iii) report immediately to that manufacturer and, if so required by the Minister, report to the Minister all serious adverse reactions encountered during the clinical testing, and

      • (iv) account to the manufacturer for all quantities of the new drug received, where so requested by the manufacturer.

  • (1.1) This section applies only in respect of a new drug for veterinary use.

  • (2) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator unless that manufacturer has, in respect of all previous sales of that new drug to any qualified investigator,

    • (a) kept accurate records of the distribution of that new drug and of the results of the clinical testing and has made those records available to the Minister for inspection on the request of the Minister; and

    • (b) immediately reported to the Minister all information he has obtained with respect to serious adverse reactions.

  • (3) The Minister may notify the manufacturer of a new drug that sales of that new drug to qualified investigators are prohibited if, in the opinion of the Minister, it is in the interest of public health to do so.

  • (4) Notwithstanding subsection (1), no manufacturer shall sell a new drug to a qualified investigator if the Minister has notified the manufacturer of that drug that such sales are prohibited.

  • (5) Paragraph (1)(c) does not apply to a radiopharmaceutical as defined in section C.03.201 or to a component or kit as defined in section C.03.205.

  • SOR/79-236, s. 5
  • SOR/85-143, s. 4
  • SOR/87-511, s. 1
  • SOR/93-202, s. 26
  • SOR/95-411, s. 7
  • SOR/2001-203, s. 6
  • SOR/2018-69, s. 27
  •  (1) Every manufacturer who files a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing of a new drug for veterinary use shall, in addition to any information and material that is required under section C.08.002, C.08.002.01, C.08.002.1, C.08.003 or C.08.005, include in the submission or supplement

    • (a) [Repealed, SOR/2018-84, s. 10]

    • (b) a sectional report in respect of each human, animal and in vitro study included in the submission or supplement;

    • (c) a comprehensive summary of each human, animal and in vitro study referred to or included in the submission or supplement; and

    • (d) a submission certificate in respect of all information and material contained in the submission or supplement and any additional information or material filed to amend the submission or supplement.

  • (2) A sectional report referred to in paragraph (1)(b) shall include

    • (a) a summary of each study included in the submission or supplement;

    • (b) a summary of any additional information or material filed to amend the submission or supplement; and

    • (c) where raw data is available to the manufacturer in respect of a study,

      • (i) a summary of the data,

      • (ii) a cross-referencing of the data to the relevant portions of the sectional report,

      • (iii) a description of the conditions under which the experiments from which the data were obtained were conducted,

      • (iv) the details of the data treatment process, and

      • (v) the results and conclusions of the study.

  • (3) The comprehensive summary referred to in paragraph (1)(c) shall include a summary of the methods used, results obtained and conclusions arrived at in respect of all studies referred to or included in the submission or supplement and shall be cross-referenced to the relevant portions of the sectional reports.

  • (4) The submission certificate referred to in paragraph (1)(d) shall

    • (a) certify that all information and material included in the submission or supplement and any additional information or material filed to amend the submission or supplement are accurate and complete, and that the sectional reports and the comprehensive summary correctly represent the information and material referred to or included in the submission or supplement; and

    • (b) be signed and dated by

      • (i) the senior executive officer in Canada of the manufacturer filing the submission or supplement, and

      • (ii) the senior medical or scientific officer of the manufacturer.

  • (5) [Repealed, SOR/2018-84, s. 10]

  • (6) Every manufacturer who has filed a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission, a supplement to any of those submissions or a submission for the clinical testing of a new drug for veterinary use and who has any relating clinical case reports or raw data that were not included in the submission or supplement shall keep those reports or data and shall, within 30 days after receiving a written request from the Minister, submit them to the Minister.

  • SOR/85-143, s. 5
  • SOR/92-543, s. 1
  • SOR/94-689, s. 2(F)
  • SOR/95-411, s. 8
  • SOR/2001-203, s. 7
  • SOR/2011-88, s. 17
  • SOR/2018-84, s. 10
  •  (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 Division 5 or section C.08.002, C.08.002.01, C.08.002.1, C.08.003, C.08.005 or C.08.005.1.

  • (2) The Minister may, by notice to a manufacturer, suspend, for a definite or indefinite period, a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions if the Minister considers

    • (a) that the drug is not safe for the use represented in the submission or supplement, as shown by evidence obtained from

      • (i) clinical or other experience not reported in the submission or supplement or not available to the Minister at the time the notice of compliance was issued, or

      • (ii) tests by new methods or tests by methods not reasonably applicable at the time the notice of compliance was issued;

    • (b) that, upon the basis of new information obtained after the issuance of the notice of compliance, there is lack of substantial evidence that the drug will have the effect it is represented to have under the conditions of use prescribed, recommended or proposed by the manufacturer;

    • (c) that the submission or supplement contained an untrue statement of material fact;

    • (d) that the manufacturer has failed to establish a system for maintaining required records or has repeatedly or deliberately failed to maintain such records;

    • (e) that, on the basis of new information obtained after the issuance of the notice of compliance, the methods, equipment, plant and controls used in the manufacturing, processing and packaging of the drug are inadequate to assure and preserve the identity, strength, quality or purity of the new drug;

    • (f) that, on the basis of new information obtained after the issuance of the notice of compliance, the labelling of the drug is false or misleading or incomplete in any particular and that this defect was not corrected by the manufacturer upon receipt of a written notice from the Minister specifying the respect in which the labelling is false or misleading or incomplete; or

    • (g) that, in the case of a new drug for extraordinary use, the manufacturer has not adhered to the plan referred to in subparagraph C.08.002.01(2)(b)(ix).

  • (3) The Minister may, by notice to a manufacturer, suspend for a definite or indefinite period a notice of compliance issued to that manufacturer in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions if, after the Minister has, under section 21.31 of the Act, ordered the holder of a therapeutic product authorization referred to in subparagraph C.01.052(1)(a)(iii) to conduct an assessment of the new drug in order to provide evidence establishing that the benefits associated with the drug outweigh the risks of injury to health,

    • (a) the holder fails to comply with the order; or

    • (b) the holder complies with the order but the Minister determines that the results of the assessment are not sufficient to establish that the benefits associated with the drug outweigh the risks of injury to health.

  • SOR/95-411, s. 9
  • SOR/2001-203, s. 8
  • SOR/2011-88, s. 18
  • SOR/2018-69, s. 27
  • SOR/2018-84, s. 11
  • SOR/2020-262, s. 5
  •  (1) Where a manufacturer has received a notice of compliance issued in respect of a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission, an abbreviated extraordinary use new drug submission or a supplement to any of those submissions, the manufacturer shall establish and maintain records, in a manner that enables an audit to be made, respecting

    • (a) animal or clinical experience, studies, investigations and tests conducted by the manufacturer or reported to him by any person concerning that new drug;

    • (b) reports from the scientific literature or the bibliography therefrom that are available to him concerning that new drug;

    • (c) experience, investigations, studies and tests involving the chemical or physical properties or any other properties of that new drug;

    • (d) any substitution of another substance for that new drug or any mixing of another substance with that new drug;

    • (e) any error in the labelling of that new drug or in the use of the labels designed for that new drug;

    • (f) any bacteriological or any significant chemical or physical or other change or deterioration in any lot of that new drug;

    • (g) any failure of one or more distributed lots of the new drug to meet the specifications established for that new drug in the submission or supplement; and

    • (h) any unusual failure in efficacy of that new drug.

    • (i) [Repealed, SOR/95-521, s. 3]

  • (1.1) The manufacturer shall retain the records respecting the information referred to in subsection (1) for at least seven years from the day on which they were established.

  • (2) A manufacturer or importer who sells a new drug for extraordinary use in accordance with section C.08.002.02 shall retain the written order for at least 15 years from the day on which the order was filled.

  • SOR/95-411, s. 10
  • SOR/95-521, s. 3
  • SOR/2011-88, s. 19
  • SOR/2014-125, s. 2

 No manufacturer shall sell a new drug unless the manufacturer has, with respect to all the manufacturer’s previous sales of that new drug, furnished to the Minister

  • (a) a summary of a record respecting any information referred to in paragraphs C.08.007(1)(a) to (c), on receipt of a request from the Minister for the summary;

  • (b) a summary of a record respecting any information referred to in paragraph C.08.007(1)(d) to (f), immediately on the manufacturer establishing the record; and

  • (c) a summary of a record respecting any information referred to in paragraph C.08.007(1)(g) or (h), within 15 days after the day on which the manufacturer established the record.

  • SOR/95-411, s. 11
  • SOR/95-521, s. 4
  • SOR/2014-125, s. 3
  • SOR/2018-84, s. 12

 Where a manufacturer has received a notice of compliance issued in respect of an extraordinary use new drug submission, an abbreviated extraordinary use new drug submission or a supplement to either of those submissions, the manufacturer

  • (a) shall adhere to the plan referred to in subparagraph C.08.002.01(2)(b)(ix); and

  • (b) shall, before the first day of October in each year and whenever requested to do so by the Minister for the purposes of assessing the safety and effectiveness of the drug to which the notice of compliance relates, provide a report on the use of the drug, including a critical analysis of any available updated information respecting the drug’s safety and effectiveness.

  • SOR/2011-88, s. 20
  •  (1) Where the Minister has decided

    • (a) to notify the manufacturer of a new drug for veterinary use that the sale of that drug to qualified investigators is prohibited, or

    • (b) to suspend a notice of compliance issued under section C.08.004 or C.08.004.01,

    the manufacturer, if dissatisfied with that decision, may require the Minister to provide him with the reasons for the decision.

  • (2) Where the manufacturer has received the reasons for a decision of the Minister pursuant to subsection (1), he may require the Minister to refer that decision to a New Drug Committee and thereupon shall provide the Minister with a statement of the reasons for his dissatisfaction and any information and material upon which he relies in support of those reasons.

  • (3) Where the Minister has been required to refer a decision to a New Drug Committee pursuant to subsection (2), he shall appoint a member of the New Drug Committee, the dissatisfied manufacturer shall appoint a member of the New Drug Committee and the two members so appointed shall appoint a third member of the New Drug Committee who shall be chairman, or, if they are unable to do so within a reasonable time, the Minister shall appoint a third member of the New Drug Committee who shall be chairman.

  • (4) Any person who is in the full-time employment of the Department or in the full-time employment of the dissatisfied manufacturer shall not be appointed a member of a New Drug Committee.

  • (4.1) A member of a New Drug Committee shall, on appointment, sign an undertaking not to disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

  • (5) The Minister shall pay the reasonable fees and costs incurred by the member of the New Drug Committee appointed by the Minister, and the dissatisfied manufacturer shall pay the reasonable fees and costs incurred by the member appointed by the dissatisfied manufacturer, and the Minister and the dissatisfied manufacturer shall each pay half of the reasonable fees and costs incurred by the chairman.

  • (6) The New Drug Committee formed pursuant to subsection (3) shall consider the reasons for the decision of the Minister, the reasons for the dissatisfaction of the dissatisfied manufacturer and any information or material in support of the reasons of the Minister or the dissatisfied manufacturer and may consider other evidence, material, information or representations.

  • (7) The New Drug Committee formed pursuant to subsection (3) shall report its findings and recommendations to the Minister.

  • (7.1) No member of a New Drug Committee shall disclose or use any information, material, data, evidence or representations considered pursuant to subsection (6).

  • (8) Where the Minister has received the findings and recommendations of a New Drug Committee, he may reconsider the decision to which those findings and recommendations relate.

  • SOR/95-411, s. 12
  • SOR/2001-203, s. 9
  • SOR/2011-88, s. 21
 
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