Government News

As applicable, each section below provides the main government regulatory bodies for each country or region. Significant news will typically be found on these sites.

News items constitute an arbitrary selection of transfusion-related regulatory updates.

 Canada

Also see Canadian Guidelines & Standards

News Updates

• Health Canada: Stakeholder Consultation on the Proposed Regulatory Framework for Blood and Blood Components (March - November 2007)

Regulatory

Health Canada

Blood and blood components

Important safety information on albumin therapy in critically ill patients (16 Aug. 2005)

Health Products and Food Branch

• Annex to the GMP Guidelines for Schedule D Drugs, Part 2: Human Blood and Blood Components
• Marketed Health Products Directorate (MHPD)
• Biologics, Radiopharmaceuticals and Genetic Therapies
  • Therapeutic Products Directorate
  • Expert Advisory Committee on Blood Regulation
  • Consultation Report - Proposed Regulatory Framework for Blood and Blood Components, Dec. 2007

Public Health Agency of Canada 

• Blood Safety Surveillance and Health Care Acquired Infections Division (BSSHCAID)  
  • Transfusion-Transmitted Injuries Section  
  • Guideline for Investigation of Suspected Transfusion Transmitted Bacterial Contamination 

 International

Australia

Australian National Blood Authority

UK

Department of Health

• Cord blood banking in the UK: an international comparison of policy and practice (12 Jan. 2009)

UK DOH: Updates to "Emergency planning: development of an integrated plan for the management of blood shortages" (NHS Blood and Transplant and Hospitals)

• Plan to address Red Cell Shortages (Oct. 2009)
• Plan to address Platelet Shortages (Oct. 2009)

European Directives & Regulations

• Report of the 2nd phase of the review of NHS pathology services in England (18 Dec. 2008)
• DOH response to report of the 2nd phase of the independent review of NHS pathology services in England (18 Dec. 2008)
  • Report of the review of NHS pathology services in England (2006)
  • Carter Review of NHS Pathology Services (official website)

USA

FDA | News | Warning letters

• CBER

Guidance for Industry: An Acceptable Circular of Information for the Use of Human Blood and Blood Components, October 2009 [includes technical correction on dosage and administration of platelet components. Updated: Dec. 2009]

Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus (Nov. 2009)

Draft Guidance for Industry: Use of Serological Tests to Reduce, the Risk of Transmission of Trypanosoma cruzi Infection in Whole Blood, and Blood Components for Transfusion and Human Cells, Tissues, and, Cellular and Tissue-Based Products (26 Mar. 2009)

 2008 Fatalities reported to FDA following blood collection and transfusion (4 Mar. 2009)

Draft Guidance for Industry (Dec. 2008). Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic. [Web page Notice]

Fatalities reported to FDA following blood collection and transfusion annual report - FY 2007  (13 Nov. 2008)

Blood Management Performance Measures Project (Joint Commission)

• Recommended areas to measure include transfusion indication, informed consent, blood administration, pre-operative testing, transfusion of multiple units and specimen testing. 

 

Also see International Guidelines & Standards