the food and drug regulations state the following:

c.08.002. (1) no person shall sell or advertise a new drug unless

(a) the manufacturer of the new drug has filed with the minister a new drug submission or an abbreviated new drug submission relating to the new drug that is satisfactory to the minister;

(b) the minister has issued, pursuant to section c.08.004, a notice of compliance to the manufacturer of the new drug in respect of the new drug submission or abbreviated new drug submission;

(c) the notice of compliance in respect of the submission has not been suspended pursuant to section c.08.006; and

(d) the manufacturer of the new drug has submitted to the minister specimens of the final version of any labels, including package inserts, product brochures and file cards, intended for use in connection with that new drug, and a statement setting out the proposed date on which those labels will first be used.

(2) a new drug submission shall contain sufficient information and material to enable the minister to assess the safety and effectiveness of the new drug, including the following:

(a) a description of the new drug and a statement of its proper name or its common name if there is no proper name;

(b) a statement of the brand name of the new drug or the identifying name or code proposed for the new drug;

(c) a list of the ingredients of the new drug, stated quantitatively, and the specifications for each of those ingredients;

(d) a description of the plant and equipment to be used in the manufacture, preparation and packaging of the new drug;

(e) details of the method of manufacture and the controls to be used in the manufacture, preparation and packaging of the new drug;

(f) details of the tests to be applied to control the potency, purity, stability and safety of the new drug;

(g) detailed reports of the tests made to establish the safety of the new drug for the purpose and under the conditions of use recommended;

(h) substantial evidence of the clinical effectiveness of the new drug for the purpose and under the conditions of use recommended;

(i) a statement of the names and qualifications of all the investigators to whom the new drug has been sold;

(j) a draft of every label to be used in conjunction with the new drug;

(k) a statement of all the representations to be made for the promotion of the new drug respecting

(i) the recommended route of administration of the new drug,

(ii) the proposed dosage of the new drug,

(iii) the claims to be made for the new drug, and

(iv) the contra-indications and side effects of the new drug;

(l) a description of the dosage form in which it is proposed that the new drug be sold;

(m) evidence that all test batches of the new drug used in any studies conducted in connection with the submission were manufactured and controlled in a manner that is representative of market production; and

(n) for a drug intended for administration to food-producing animals, the withdrawal period of the new drug.

c.08.005.1. (1) every manufacturer who files a new drug submission, an abbreviated new drug submission, a supplement to a new drug submission, a supplement to an abbreviated new drug submission or a preclinical new drug submission shall, in addition to such information and material as is required under sections c.08.002, c.08.003 and 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.