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What is a Regulatory Framework?

Regulatory framework for blood and blood components Transfusion Medicine Residency Program May 31, 2011. What is a Regulatory Framework?. Legislative Acts and Regulations Non-legislative Policies Guidelines Directives Standards.

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What is a Regulatory Framework?

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  1. Regulatory framework for blood and blood componentsTransfusion MedicineResidency ProgramMay 31, 2011

  2. What is a Regulatory Framework? • Legislative • Acts and Regulations • Non-legislative • Policies • Guidelines • Directives • Standards

  3. Regulatory framework for blood and blood componentsLegislative • Food and Drugs Act • Definition of drugs includes blood and blood components (Schedule D) • Drugs not be to distributed unless safe • Enforcement and powers of inspectors • Regulation-making authority • Food and Drug Regulations, Part C (Drugs) • Division 1 General requirements • Division1a Establishment Licensing • Division 2 Good Manufacturing Practices • Division 4 Preparation from human sources (pooled blood plasma, pooled blood serum) and plasmapheresis

  4. Regulatory framework for blood and blood componentsNon-Legislative (1) • Policies (Interpretations of the purpose and intent of the Food and Drugs Act and Regulations) • The Distinction Between Advertising and Other Activities (2000) • Guidelines (To assist in the interpretation of the policies governing statutes and regulations) • GMP for Schedule D Drugs, Part 2 - Human Blood and Blood Components (1999) • Management of Blood Establishment Submissions (2006) • Regulatory Requirements for Blood Establishment Information Technology Submission (Draft 2008) • Directives (Request for action) • Implementation of Prestorage Leukoreduction of Cellular Blood Components (1998) • Donor Exclusion to Address Theoretical Risk of Transmission of vCJD through the Blood Supply (1999, 2000, 2001, 2005) • Simian Foamy Virus (2006)

  5. Regulatory framework for blood and blood componentsNon-Legislative (2) • Consensus standards • Developed by Standards Development Organizations • International Organization for Standardization (ISO) • Canadian Standard Association (CSA) • American National Standards Institute (ANSI) • Participation is opened to all affected interests (manufacturers, vendors, users, consumer groups, governments, professional and/or research organizations, etc.) • Balanced is maintained among competing interests • Due process assures that all views will be considered and that appeals are possible • Are used within a regulatory framework • e.g., CSA Standard - Blood and Blood Components (Z902) • Non-consensus standards • Association/Industry Standards • Representation and review is limited • Are not used within a regulatory framework • e.g., AABB’s Standards for Blood Banks and Transfusion Services

  6. Use of consensus standards in a regulatory framework • Reference consensus standard directly in Regulations • The standard can not be in conflict with any statute, regulations, or policies under which the regulator operates; • The standard is national or international in scope and approved by a Standards Development Organizations accredited by the Standards Council of Canada; • e.g., CAN/CSA-ISO 13485:2003 • Reference specific clauses/sections of the standard in the regulations • e.g., Safety of Human Cells Tissues and Organs for Transplantation Regulation and the CSA Standards (Z902) • Write the requirements directly in the Regulations • Reference a Health Canada technical document in the Regulations • Recognize or translate, as applicable, the Standard in Guidelines

  7. Regulatory Oversight Where does it start and end in relation to the management of the blood system?

  8. BGTD (Health Canada) HPFBI (Health Canada) Major/Serious other ATE SDE E/A&PDI Inspections Procedural Change CBS MDB (Health Canada) CBER (FDA) Procedures and Labels (Plasma for Fractionation) Special Access Specimens for confirmatory testing, Waste units Medical Laboratory Functions Irradiators Provincial MOH CNSC TDG Who Are The Regulators?The Big Picture

  9. Scope of processes subject to licence amendments

  10. Type of changes subject to licence notification • Addition of a new licensed test (Chagas) • Addition of QC testing (hemolysis) • Change in product expiry (5-day Plasma) • New transportation system for raw material • Change to Donor Selection Criteria (Age)

  11. Impact of workload and BGTD’s review times (2009)

  12. Incident Reporting Requirements

  13. Reporting of Adverse EventsLegend • Mandatory Reporting • Voluntary Reporting • Feedback Link • BGTD Biologics & Genetic Therapies Directorate • CBS Canadian Blood Services • HPFBI Health Products & Foods Branch Inspectorate • MDB Medical Devices Bureau • MHPD Marketed Health Products Directorate • PHAC Public Health Agency of Canada • PDI Post-Donation Information • SDE Serious Donor Event • TTISS Transfusion Transmitted Injuries Surveillance System

  14. Donor PDI or SDE Error Or Accident Product Problem CBS Centre CBS Staff Hospital E/A Reportable in 24 hr or less CBS Head Office HPFBI BGTD Errors, Accidents, Post-Donation Information & Serious Donor Events

  15. Plasma Protein Products Blood & Blood Components Hospital CBS Fractionator If Problem results from Error or Accident If Problem results from Error or Accident BGTD Product Problems

  16. HPFBI Supplier MDB CBS Head Office BGTD If CBS products affected CBS Centres If CBS products affected Hospital Supplier Notifications

  17. Plasma Protein Products Hospital Provincial Blood Office MHPD CBS TTISS Fractionator BGTD Adverse Reactions to Transfusion Blood & Blood Components PHAC

  18. Adverse Events reported to CBS Between 1 April 2009 and 31 March 2010, 113 adverse events were reported to Canadian Blood Services. TRALI or suspected TRALI 33 Febrile reaction 24 TACO 16 Anaphylactic 6 Suspected bacterial 4 Delayed hemolytic 6 Allergic 3 PTP 1 Miscellaneous 20

  19. Regulatory Compliance • Monitor release of new / revised Regulations & Standards • Change Control Process • Work Instructions for staff

  20. Regulatory Compliance • Corporate Audits • Supplier Audits • Inspection by Regulator

  21. In summary • Scope of processes subject to licence notification: • For product related processes, regulatory oversight exercised through the licence notification process • For most of the support processes, regulatory oversight exercised through the audit/inspection process • Type of changes subject to licence notification: • Risk based • Reporting requirements: • Major, serious or critical

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