Connaught Medical Research Laboratories
The main index of new product development at the Connaught Medical Research Laboratories is to be found in the applications for licence approval made to the Canadian Control Authorities, namely, the Health Protection Branch, Department of National Health and Welfare and to the U. S. authorities, the Division of Biologics Standards, National Institutes of Health, Bethesda, Maryland, U. S. A.
Submissions for licence approval are made in two steps. In Canada, we must obtain approval to carry out clinical trials on any prospective new drug. This involves a preclinical compliance under Section C. 08.005 of the Regulations. We must submit all details of manufacture, testing, animal studies, quality control procedures and proposed clinical trial protocol together with statements from the clinical investigators who will use the product. When the clinical trials are completed satisfactorily and methods of manufacture, testing, labelling and quality control have been fully on established, we then submit all these data in the form of a New Drug Submission under Section C, 08, 002 of the Regulations.
The collection and compilation by Connaught and review by the Control Authorities, of these data, may take anywhere from several months to several years depending upon the complexity and "newness" of the drug.
Should we wish to change any aspect of production, testing, composition, labelling, we are obliged to submit an amendment to our original Submission. Depending upon the degree of change involved, an amendment may require several months or more for approval.
Similarly, if we wish to distribute a biological product in the U.S. A we must go through an IND (Investigational New Drug) and a New Drug licence application under the U. S. Public Health Service Regulations, Part 73.
The listing which follows comprises those products which have been developed and licensed in Canada and the U. S. A. during the last 10 years, approximately, and those which are at present at some stage of clinical evaluation for approval by Canadian authorities.
A CANADA
1. ALG (Antilymphocyte Globulin Equine):
This equine gamma globulin is prepared by immunizing horses with adjuvanted human thymocyte membranes, absorbing hemagglutinins and antibodies to human serum proteins from the horse serum, then removing other serum proteins to yield the gamma fraction of more than 95% purity.
This experimental product received a Notice of Compliance for clinical trial on February 9, 1971, amended on August 23, 1971, for a product of greater purity. [end of text]
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