Regulatory Processes and the Blood Service
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Tutorial for Transfusion Medicine Residents Regulatory Processes and the Blood Service
description
Regulatory Processes and the Blood Service. Tutorial for Transfusion Medicine Residents. What are Regulations and Standards?. Standards Usually published by non-governmental organisations (e.g. CSA, CSTM, AABB, ISO), but foreign Regulations also included Compiled by panels of experts - PowerPoint PPT Presentation
Transcript of Regulatory Processes and the Blood Service
Tutorial for Transfusion Medicine Residents
Regulatory Processesand the
Blood Service
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• Standards– Usually published by non-governmental organisations
(e.g. CSA, CSTM, AABB, ISO), but foreign Regulations also included
– Compiled by panels of experts– Represent what is considered “competent” and
“reasonable”– Compliance is voluntary– May be used as evidence in a civil suit for negligence
What are Regulations and Standards?
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• Some of the Standards that are applicable to CBS:
–CSA Standard Z902-04, Blood and Blood Components
–CSA Standard Z900.1-03, Cells, Tissues and Organs for Transplantation and Assisted Reproduction: General Requirements
–CSA Standard Z900.2.5-03, Lymphohematopoietic Cells for Transplantation
–US Code of Federal Regulations (CFR)
What are Regulations and Standards?
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• Regulations– Published by government agencies– Compiled by agency staff in consultation with
the industry and the public– Represent minimum requirement– Compliance is mandated– Failure to comply can be prosecuted, usually
under Criminal Code
What are Regulations and Standards?
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• Some of the Regulations CBS must comply with:
– Food and Drug Regulations• Division 2 - Good Manufacturing Practices
• Division 4 - Biologics
– Health Canada Directive, Technical Requirements to address the Safety of Cells, Tissues and Organs for Transplantation (July, 2005)
– Nuclear Safety and Control Act– Laboratory & Specimen Collection Centre Licensing Act
(Ontario) & Laboratories Regulations– Medical Laboratory Licensing Act & Regulations
(Saskatchewan)
What are Regulations and Standards?
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Who are the Regulators? The Big Picture
CBS
HPFBI
CBER
CNSCProvincial
MOH
MDB
BGTD
Medical Laboratory FunctionsIrradiators
Procedures and Labels(Plasma for Fractionation)
InspectionsE/A&PDI ATE
SDE
Blood CollectionSystems
Test SystemsProcedural
Change
Major/Serious other
TDG
Specimens forconfirmatory testing,
Waste units
Special Access
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Who are the Regulators? HEALTH CANADA
Agencies
Chief Public Health Officer
Public Health Agency of Canada
Canadian Institutes of Health Research
Hazardous Materials Information Review
Board
Patented Medicine Prices Review Board
Ministry of Health
Deputy MinisterAssociate Deputy Minister
Audit & Accountability Bureau
Chief Financial Officer Branch
Corporate Services Branch
First nations and Inuit Health Branch
The Office of the Chief Dental Officer
Health Environments and Consumer Safety Branch
Health Policy Branch
Health Products and Food Branch
Communications, Marketing and Consultation Directorate
Departmental SecretariatLegal Services
Office of the Chief Scientist Office of the Cameron Visiting Chair
Pest Management Regulatory Agency
British Columbia & Yukon Region
Alberta and NWT Region
Manitoba & Saskatchewan Region
Ontario & Nunavut Region
Quebec Region
Atlantic Region
Regional Presence
Branches ofHealth Canada
From A. Arias, “Role of BGTD”, PAHO Workshop, Managua, 2006-10-03/05
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Who are the Regulators? – HEALTH CANADAHealth Products
AndFoodsBranch
Biologics&
Genetic Therapies Directorate
Therapeutic Products
Directorate
Health Products& FoodsBranch
Inspectorate
MarketedHealth Products
Directorate
Policy , Planning & International Affairs
Directorate
Drugs
Medical Devices
Special AccessProgram
NaturalHealth
ProductsDirectorate
Veterinary DrugsDirectorate
FoodDirectorate
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Biologics & Genetic Therapies Directorate
Centre for Policy and Regulatory Affairs
Centre for Biologics Evaluation
Centre for Evaluation of Radiopharmaceuticals & Biotherapeutics
Centre for Biologics Research
Blood, Tissues, Organs,& XenograftsClinical Evaluation
Hemostatic Agents & Blood SubstitutesPlasma Derivatives
Vaccines
Who are the Regulators? – HEALTH CANADA
From A. Arias, “Role of BGTD”, PAHO Workshop, Managua, 2006-10-03/05
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Where Do I Find The Regulations?Food and Drugs Act
– Requires that drugs must be safe and efficacious.
– Applies only to “Sale” or distribution of drugs (whether money or other consideration is returned or not).
– Regulations, Guidelines and Directives establish technical and labelling requirements for specific products
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Where do I find the Regulations?
• Food and Drug Regulations
• Division 2 - Good Manufacturing Practices
– Health Canada also publishes a Guideline on interpretation and application of these Regulations
– Guideline includes Annexes for Biologics and for Blood and Blood Components
– Principal thrust – there must be a Quality System and a Quality Department
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Where do I find the Regulations?
• Food and Drug Regulations
• Division 4 - Biologics
– Only a small portion of this Division deals with Blood or Blood Components.
– Most of this (C.04.400 to C.04.423) addresses Source Plasma (plasma collected by apheresis for the production of plasma fractions).
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Where do I find the Regulations?• CSA Standard Z902-04, Blood and Blood Components
– Will be referenced in new Regulations to be issued for comment in the first half of (calendar) 2008.
– New Regulations will include requirements applicable to hospital transfusion services.
– New version of the standard currently in approval process.
• CSA Standard Z900.1-03, Cells, Tissues and Organs for Transplantation and Assisted Reproduction: General Requirements; January 2003
• CSA Standard Z900.2.5-03, Lymphohematopoietic Cells for Transplantation; February 2003
– Regulations referencing these standards have been published to take effect on 2007-12-07. Will become part of Division 4.
– Guidance Document has been published for comment.
– New versions of the standards are currently at press.
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• The Act and the Regulations are enforced to the letter.
• Alternative approaches having equivalent outcomes are not permitted unless the regulatory text includes terms such as “adequate” or “effective” or “sufficient”.
• Guidelines and Standards can be interpreted (Is the intent achieved?)
Where do I find the Regulations?
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Where Do I Find The Regulations?• Nuclear Safety and Control Act
Protection of staff and publicMost recent concern – preventing theft of isotopes
• Laboratory & Specimen Collection Centre Licensing Act (Ontario) & Laboratories Regulations
• Medical Laboratory Licensing Act & Regulations (Saskatchewan)Define requirements for operators.
• US Code of Federal RegulationsApplies to plasma entering USA for fractionationMost requirements waived via Import for Export Exemption
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What are the Rules?Change Process – Food & Drug Regulations• Biologics manufacturers must obtain an
Establishment Licence for their facilities and must have each drug they make listed in an Annex to the Licence.
• Licence applications must describe the facilities, equipment (including computer systems) and manufacturing processes used and must identify the personnel in charge. Must also submit Monograph describing drug and its use and labels applied to product.
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What are the Rules?Change Process (continued)• The Regulator must be notified in advance of
significant changes to information contained in the Licence Application.
• Changes to labels must be submitted.• Labelling (other materials describing the
product) must be consistent with the Monograph.)
• Hospital-based establishments are exempted from these rules.
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What are the rules?Submissions to BGTD
Category I II III IV
Potential for adverse effect on safety or efficacy
None Administrative
Change
Minimal Moderate Substantial
BGTD Performance Target(90-day administrative default for all Categories)
NoneCBS must notify within 15 days
20
calendar days
+ 5 days screening
30
calendar days
+ 15 days screening
90
calendar days
+ 15 days screening
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Adverse Reactions to Transfusion
Hospital
Provincial
Blood Office
TTISS
CBS
BGTD
Fractionator
MHPD
Plasma Protein Products
Blood & Blood Components
CTOs
monthly
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Errors, Accidents, Post-Donation Information & Serious Donor Events
CBS
Centre
Donor
CBS
Head Office
BGTD
PDI or SDE
Hospital CBS Staff
Product Problem
ErrorOr
Accident
HPFBI
E/AReportable
in 24 hr or less
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What are the rules?Reporting to BGTD
Type of Occurrence Reporting timeframe(from discovery by CBS)
Errors
Accidents
Post-Donation Information
Incidents (IT only)
4 hours if “Catastrophic”
24 hours if Major/Serious/”Critical”
15 days if Significant
45 days for most
Adverse Reaction 24 hours if life-threatening or fatal
15 days for others
Adverse Donor Event 24 hours if life-threatening or fatal
15 days if Donor hospitalized
Quarterly for others
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Questions ?
. . . and on behalf of Q&RA,
Thank You.
