Regulatory Requirements for Collection, Administration and Transfusion of Blood and Blood Products

Author(s): Monika Rani, Raghuvansh Kumar, Gagandeep Kaur, Pawan Krishan

Journal Name: Applied Clinical Research, Clinical Trials and Regulatory Affairs (Discontinued)
Continued as Applied Drug Research, Clinical Trials and Regulatory Affairs

Volume 4 , Issue 1 , 2017

Graphical Abstract:


Blood is considered as a life saving tissue. World Health Organization (WHO) has considered “Blood” under the definition of “Drug,” in Drug and Cosmetic Act, 1940. For the first time, in 1975, WHO World Health Assembly (WHA) under the resolution WHA (28.72), established the principles and guidelines for the managed and coordinated blood systems. For over fifty years, expert committee on biological standardization (ECBS), has been playing a key role in developing and updating norms and standards for collection, processing, storage, transfusion and manufacturing of pharmaceuticals derived from blood. In 2010, under the resolution WHA (63.12), WHO noted a number of international concerns about shortage of plasma derived products, unequal access of blood and blood products globally, quality and safety of blood and blood product transfusion. So, this review summarizes various regulatory requirements, which need to be followed for safety and quality assurance systems to control the quality and safety of blood and blood products and provision of safe blood products to meet the clinical need of patients.

Keywords: Blood, blood products, blood regulatory network, regulatory guidelines of blood products, safety and quality assurance, blood transfusion.

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Article Details

Year: 2017
Published on: 10 November, 2016
Page: [43 - 54]
Pages: 12
DOI: 10.2174/2213476X03666161110124555
Price: $25

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