Dr H. Zhou, China
It is well known that quality and safety of blood products are of paramount importance for the health of the human being. In order to strengthen the management of blood products, prevent and control prevailing diseases, and safeguard the quality of products, the State Council specifically promulgated the Regulation of Control of Blood Products in 1996.
Source plasma is collected by a plasmapheresis system. Plasma intended for further manufacturing into plasma derivatives is subject to a minimum of five tests for viral markers: hepatitis B surface antigen (HBSAg); anti-human immunodeficiency virus (HIV) 1 and 2; anti-hepatitis C virus (HCV); syphilis; and alanine-aminotransferase.
In China, the quality of source plasma is rigorously controlled. The plasmapheresis centres must be legally authorized by provincial authorities responsible for liaison and management of the quality of plasma between manufacture and plasma centres. In order to ensure plasma derived product safety, China has decided to incorporate at least one specific viral inactivation or removal step in the manufacturing process. The following specific methods for virus inactivation and removal have been used: heat treatment with dry and wet heat; solvent/detergent; low pH; and combined methods.
Another concern involves the transmission of non-enveloped viruses, such as hepatitis A viruses, which are prevalent in China and cannot be inactivated by solvent/detergent treatment. In such cases, virus removal filtration (so-called nanofiltration), which is applied during product downstream processes, has been partially introduced into China in connection with some plasma products. Other methods, such as solvent/detergent, have also been introduced.
In China, plasma products are regarded as drugs. Therefore, the regulation of new plasma product evaluation is similar to that of a new drug. Prior to being placed on the market, any plasma product must be granted a marketing authorization by the State Drug Administration.