WHO global benchmarking tool plus rev. VI+ ver. 1. Approval of blood and blood components, including plasma for fractionation (product and/or process approval) (AB)

Overview

The granting of approval of products (i.e., blood and blood components including plasma for fractionation) or processes (i.e., preparation of blood and blood components including plasma for fractionation) is critical to any National Regulatory Authority (NRA). Approval of blood and blood components, including plasma for fractionation (product and/or process approval) (AB) refers to a procedure for approval of blood and blood components, including plasma for fractionation, or to the process for preparation of these products after it has undergone an evaluation to determine the safety, efficacy and quality of the product and the appropriateness of the product information. The objective of this regulatory function is to provide a system that ensures that only products that have been duly authorized by the NRA are allowed to be manufactured, imported, distributed, sold or supplied to end‐users. The process of assessment for AB includes the review of quality, safety and efficacy data submitted by the applicant. The same standards should be applied to imported and locally manufactured blood and blood components.