Regulatory control of blood products in Canada.

Blood products are considered as biological drugs in Canada and are regulated under The Food and Drugs Act. Before a biological drug may be sold, the manufacturer must file a new drug submission with the Bureau of Biologics and receive a notice that the submission complies with the regulations. In addition the manufacturer must comply with the requirements for a license, including the detailed description of manufacturing facilities, qualifications of personnel, and standard operating procedures of all manufacturing steps. To verify the information provided by the manufacturer, senior scientists of the Bureau conduct an inspection of the manufacturing premises. In order to ensure the safety and potency of the product, the Bureau authorizes the sale of the product on a lot by lot basis. Samples of each lot are submitted to the Bureau laboratories for testing. In November 1984 the Bureau required manufacturers to treat coagulation products by a method proven to inactivate HTLV-III/LAV. While immune globulin preparations have not been associated with virus transmission in recipients, the Bureau tested 22 lots of various immune globulin products for HTLV-III/LAV antibodies. Using the Western Blot assay 9 lots were found antibody positive. Although these lots are not considered infectious, further studies are required from manufacturers to demonstrate by virus isolation attempts and virus "spiking" studies that the fractionation procedure eliminates potentially infectious virus.