Food and Drug Regulations

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) a copy of all clinical case reports respecting any subject of a study included in the submission or supplement if that subject has died, suffered a serious adverse reaction or an unexpected adverse reaction, or the study, insofar as it relates to this subject, has not been completed;

• (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) No person shall sign a submission certificate if a sectional report, comprehensive summary or any information or material included in the submission or supplement, or any additional information and material filed to amend the submission or supplement,

• (a) is false or misleading; or

• (b) contains omissions that may affect its accuracy and completeness.

(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.