WHO launched an Action Framework to advance universal access to safe, effective and quality-assured blood products 2020–2023 (Action Framework) on 27 February 2020. The Action Framework aims to provide strategic direction to global efforts to address present barriers to the safety and availability of blood products. One of the strategic objectives of this Action Framework is to ensure that each Member State has an appropriate national framework of regulatory controls, national standards and quality assessment programmes. To this end, each Member State should have regulatory mechanisms established to undertake premarket review, register, license and certify blood establishments and blood products, as well as associated substances. National standards and minimum product and performance specifications, national guidelines for Good Manufacturing Practice (GMP) in blood services and hospitals, transfusion practices and clinical use of blood, hemovigilance and pharmacovigilance, as well as quality management should be developed and implemented. WHO is required to provide technical assistance and to support blood regulatory capacities in the Member States.
The following topics on key elements of blood regulations will be presented during the four-day webinar: The Value of Blood and Blood Product and Elements of a National Blood Policy; Functions of the blood regulator; GMP for Blood Establishments; Regulation of blood/blood components as essential medicines; Blood product standards; Product testing; Conduct of inspections; Prevention of Transfusion Transmissible Infections: selection of donors & laboratory testing, and Elements of a hemovigilance system. Country and regional experiences in building blood regulation will be shared and Practical exercises will also be organized on day 4. The participants of the live webinar will be blood regulators officials in the Ministries of Health who are responsible for national blood programmes and directors of the major blood establishments.