FALK2016年12月23日发来稿注册部审核部分Clinical Study Agreement • December 27th, 2016
Contract Type FiledDecember 27th, 20161、API: means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in the production of a medicinal product, becomes an active ingredient of the drug product. Such substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body.