drug control - preclinical submissions

clinical trials: preclinical submissions


during clinical trials, a preclinical submission must be filed with the minister of health. preclinical reports must contain the following information (source: food and drug regulations section c.08.005.1):

(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;