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

C.08.004.01 (1) Subject to section C.08.004.1, the Minister shall, after completing an examination of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

• (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

• (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

(2) If an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, the manufacturer who filed the submission or supplement may amend the submission or supplement by filing additional information or material within 90 days after the day on which the Minister issues a notice to the manufacturer under paragraph C.08.004.01(1)(b) or within any longer period specified by the Minister.

(3) Subject to section C.08.004.1, the Minister shall, after completing an examination of any additional information or material filed in respect of an extraordinary use new drug submission or an abbreviated extraordinary use new drug submission or a supplement to either submission,

• (a) if that submission or supplement complies with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, and section C.08.005.1, issue a notice of compliance; or

• (b) if that submission or supplement does not comply with section C.08.002.01, C.08.002.1 or C.08.003, as the case may be, or section C.08.005.1, issue a notice to the manufacturer to that effect.

(4) A notice of compliance issued in respect of a new drug for extraordinary use on the basis of information and material contained in a submission filed pursuant to section C.08.002.1 shall state the name of the Canadian reference product referred to in the submission and shall constitute a declaration of equivalence for that new drug.

C.08.004.1 (1) The following definitions apply in this section.

abbreviated new drug submission

abbreviated new drug submission includes an abbreviated extraordinary use new drug submission. (présentation abrégée de drogue nouvelle)

innovative drug

innovative drug means a drug that contains a medicinal ingredient not previously approved in a drug by the Minister and that is not a variation of a previously approved medicinal ingredient such as a salt, ester, enantiomer, solvate or polymorph. (drogue innovante)

new drug submission

new drug submission includes an extraordinary use new drug submission. (présentation de drogue nouvelle)

pediatric populations

pediatric populations means the following groups: premature babies born before the 37th week of gestation; full-term babies from 0 to 27 days of age; and all children from 28 days to 2 years of age, 2 years plus 1 day to 11 years of age and 11 years plus 1 day to 18 years of age. (population pédiatrique)

(1.1) For the purposes of the definition innovative drug in subsection (1), a medicinal ingredient is not considered to be approved in a drug by reason of the Minister having issued or amended an authorization under the ISAD Interim Order in respect of a COVID-19 drug that contains the medicinal ingredient.

(2) The purpose of this section is to implement Articles 20.48 and 20.49 of the Agreement between Canada, the United States of America and the United Mexican States, as defined in the definition Agreement in section 2 of the Canada–United States–Mexico Agreement Implementation Act, and paragraph 3 of Article 39 of the Agreement on Trade-related Aspects of Intellectual Property Rights set out in Annex 1C to the Agreement Establishing the World Trade Organization, as defined in the definition Agreement in subsection 2(1) of the World Trade Organization Agreement Implementation Act.

(3) If a manufacturer seeks a notice of compliance for a new drug on the basis of a direct or indirect comparison between the new drug and an innovative drug,

• (a) the manufacturer may not file a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission in respect of the new drug before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug; and

• (b) the Minister shall not approve that submission or supplement and shall not issue a notice of compliance in respect of the new drug before the end of a period of eight years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug.

(4) The period specified in paragraph (3)(b) is lengthened to eight years and six months if

• (a) the innovator provides the Minister with the description and results of clinical trials relating to the use of the innovative drug in relevant pediatric populations in its first new drug submission for the innovative drug or in any supplement to that submission that is filed within five years after the issuance of the first notice of compliance for that innovative drug; and

• (b) before the end of a period of six years after the day on which the first notice of compliance was issued to the innovator in respect of the innovative drug, the Minister determines that the clinical trials were designed and conducted for the purpose of increasing knowledge of the use of the innovative drug in those pediatric populations and this knowledge would there-by provide a health benefit to members of those populations.

(5) Subsection (3) does not apply if the innovative drug is not being marketed in Canada.

(6) Paragraph (3)(a) does not apply to a manufacturer if the innovator consents to the filing of a new drug submission, a supplement to a new drug submission, an abbreviated new drug submission or a supplement to an abbreviated new drug submission by the manufacturer before the end of the period of six years specified in that paragraph.

(7) Paragraph (3)(a) does not apply to a manufacturer if the manufacturer files an application for authorization to sell its new drug under section C.07.003.

(8) Paragraph (3)(b) does not apply to a manufacturer if the innovator consents to the issuance of a notice of compliance to the manufacturer before the end of the period of eight years specified in that paragraph or of eight years and six months specified in subsection (4).

(9) The Minister shall maintain a register of innovative drugs that includes information relating to the matters specified in subsections (3) and (4).

C.08.005 (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.

C.08.005.1 (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.

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 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.