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Update on International Agreements

Update on International Agreements. March 17, 2005 Mark Weinstein, Ph.D. Office of Blood Research and Review CBER, FDA. World Health Organization.

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Update on International Agreements

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  1. Update on International Agreements March 17, 2005 Mark Weinstein, Ph.D. Office of Blood Research and Review CBER, FDA

  2. World Health Organization • Expert Committee on Biological Standardization (ECBS)Establishes international reference materials; provides advice about blood and blood products • Collaborating Center for Biological StandardizationFDA laboratories provide standards, and work collaboratively on standards development for in vitro diagnostic devices, plasma proteins, NAT, blood typing sera, and diagnosis and study of TSEs • Global Collaboration for Blood Safety (GCBS),Created by WHO,a forum that facilitates international collaboration in blood safety and availability through dialogue, non-binding recommendations and cooperative work

  3. “Harmonization” • International Conference on Harmonization (ICH)Regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions discuss scientific and technical aspects of product registration • European Directorate for the Quality of Medicines, European Pharmaocopoeia Commission (EDQM/EP), Group of Experts 6B.FDA Observer status will help to harmonize analytical assay methods and potency standards used in Europe and the US • Council of EuropeGuide to the Preparation, Use and Quality Assurance of Blood Components

  4. Collaboration • National Institute of Biological Standards and Control (NIBSC) UK institute; main source of potency reference materials and organization of collaborative studies on reference materials • International Society on Thrombosis and Hemostasis (ISTH), Scientific and Standardization Subcommittee (SSC) works on: potency standards, clinical trial designs, patient registries, surveillance,

  5. Information Sharing Agreements • European Union: European Commission and the European Medicines Agency • Health Products and Food Branch (HPFB)/Health Canada • SwissMedic, Switzerland • Therapeutics Goods Administration, Australia • Pharmaceutical and Food Safety Bureau, Pharmaceutical and Medical Devices Agency, Japan • Health Sciences Authority , Republic of Singapore

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