Biovigilance: A global perspective

Abstract

A biological is a substance which either comprises, contains, or is derived from human cells or human tissues. The use of biological products is associated with the risk of infection transmission, allergic reactions, and other adverse events (AEs). The science and activities relating to the detection, assessment, understanding, and prevention of AEs or any other problems related to biological products (blood, cells, tissues, organs, and vaccine in international perspective) are termed as biovigilance. With more and more biologicals being marketed and the rapid revolutionary changes in transplant-related services, the importance of biovigilance is increasing day by day. Although specific types of vigilance systems (pharmacovigilance and materiovigilance) exist, activities related to “biovigilance” are still in an infancy stage. Many developed countries such as the USA, Europe, and Australia have implemented nationwide biovigilance programs. In India, the National Institute of Biologicals, in collaboration with the Indian Pharmacopoeia Commission, has launched the Biovigilance Programme of India. In this article, the biovigilance systems of different countries across the globe have been reviewed along with highlights of the current biovigilance needs.

Keywords

• Adverse events
• biological products
• biovigilance