Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation

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1 Canadian Regulations Safety of Human Cells, Tissues and Organs (CTO) for Transplantation Presentation to the American Association of Tissue Banks Savannah, Georgia March 2008

2 Health Canada Update Marianne Tang Manager CTO Regulatory Policy Unit Biologics and Genetic Therapies Directorate Health Products and Food Branch Health Canada (613)

3 Overview Health Canada s mandate and authority New CTO regulatory framework Implementing the new regulations Establishment Registration Process Adverse Reaction & Error/Accident Reporting Transitional Provisions Health Canada Guidance Document for Establishments Keep the CSA Standard current ( Standard-based regulations ) Evaluation of effectiveness of the regulations 3

4 Health Canada Principles Safety and prevention of disease transmission is key Nationally integrated approach required Transparent Clear accountability Harmonize internationally when possible, but identify areas where we can lead 4

5 Mandate To take an integrated approach to the management of risks and benefits to health related to health products and food by minimizing risk factors to Canadians while maximizing safety provided by the regulatory system authority provided under the Food and Drugs Act and Regulations emphasis on product safety and informed use 5

6 Regulating Cells, Tissues and Organs Key Considerations Federal/ Provincial/ Territorial Responsibility 10 provinces and 3 territories, each with responsibility over of management and delivery of healthcare within International Share border with US, with exchange of CTO across border in each direction 6

7 Regulating CTO Key Considerations Donor Family P/T Governments (Delivery) Liver Transplant Program Heart Transplant Program Kidney Transplant Program Patient Patient Patients Organ and Tissue Donor Donor Establishment of Origin Organ Donation Organization Lung Transplant Program Patient(s) The Need for Traceability Health Canada (Product Safety) Eye Bank Tissue Bank (Bone) Islet Cell Transplant Program Cornea Tx Programs Ortho Programs (multiple) Patient Patients Patients Tissue Bank (Heart Valves) Cardiovascular Programs Patients 7

8 New CTO Regulations Published in June 2007 and came into force on December 7, 2007, following extensive consultation over a period of 11 years with the transplant community and Canadians. Companion Guidance Document also published Regulate the safety, efficacy, and quality of CTOs as therapeutic products under the Food and Drugs Act. we therefore regulate the product, but not the practice Purpose is to minimize the potential health risks to Canadian recipients resulting from transplantation. 8

9 New CTO Regulations Reflects best practices ongoing in Canada in the field of transplantation since the mid 1990 s and enshrine these requirements into law so that transplantation will remain safe to Canadian patients. Safety regulations incorporate by reference national standards that have been developed by the Canadian Standards Association (CSA), with additional requirements for compliance monitoring and adverse reaction, error and accident reporting strategies 9

10 CTO Regulatory Framework Why Standard-Based Regulations? Balanced representation of stakeholders in development process Consensus approach may enhance future compliance Written in non-legal/regulatory language Easier to update than regulations 10

11 CSA National Standards In 2001, Health Canada funded the Canadian Standards Association (CSA) to develop the standards Published in 2003 and updated Nov 2004 Content developed by group of experts in various transplant domains: One general standard and five subset standards Cells, Tissues and Organs for Transplantation and Assisted Reproduction: General Requirements (CAN/CSA Z900.1) Tissues for Transplantation (CAN/CSA Z ) Others for organs, ocular, lymphohematopoietic, assisted reproduction 11

12 CTO Regulatory Framework Developing Standards-Based Regulations Standards are made mandatory only when: incorporated directly into regulations, or referenced in regulations Health Canada can only use sections of the standards that are: under federal authority; absolute requirements 12

13 CTO Regulations Scope Applies to organs and minimally manipulated cells and tissues Structural tissue: the processing does not alter the original characteristics that are relevant to its claimed utility for reconstruction, repair or replacement Cells and nonstructural tissue: the processing does not alter the biological characteristics that are relevant to their claimed utility Intended for allogeneic use Intended for homologous use 13

14 CTO Regulatory Framework Scope Cells and Tissues meeting any of the following criteria will be regulated under the drug or medical device regulations: more than minimally manipulated; intended for non-homologous use; have a systemic effect and depend on their metabolic activity for their primary function (except islet cells and lymphohematopoietic cells from bone marrow, peripheral blood and cord blood); subject of investigational studies or clinical trials in humans combined with non-tissue products, including drugs and devices 14

15 CTO Regulatory Framework Provisions Registration All Source Establishments (including US based) or establishments that import CTO have to register Canadian Establishments may only import CTO from establishments that have registered with Health Canada Source Establishment The term source establishment refers to the source of the CTO that has undergone all processing and is now safe for transplantation It is responsible for the processing of CTO, whether it is carried out on its behalf or accomplished by itself It is also responsible for determining whether CTO are safe for transplantation Processing This activity includes the screening, testing and suitability assessment of donors (as set out in the CSA standard), as well as the testing and measurements performed on the CTO after retrieval (e.g., microbiological tests) retrieval, preparation and preservation, packaging and labelling, quarantine, and banking of CTO 15

16 Implementing the new CTO Regulations 16

17 Establishment Registration Establishments that must register Every Source Establishment - foreign or domestic Establishments that import and distribute Exemption import directly to transplant only e.g. dentists 17

18 Establishment Registration Contents of application for registration Establishment contact information Description of CTO and activities Attestation to compliance with CTO Regulations Upon request, any relevant information required to complete the application or demonstrate compliance with the Regulations 18

19 Establishment Registration Since the June 2007 publication date of the CTO Regulations, establishments have been completing and sending their registration applications to Health Canada List of all registered establishments will be available on the Health Canada website soon 19

20 Establishment Registration Registration numbers are issued if information is complete May be refused if information is false, misleading, inaccurate or incomplete May be suspended or revoked due to serious adverse reactions or failure to comply with the Regulations All CTO Registration numbers expire on December 31 st of the year following the year in which it was issued 20

21 Establishment Registration Notification required Within 30 days of any change in information provided in the application Within 90 days of ceasing an activity and provided information on the disposition of cells/tissues in establishment s possession 21

22 Error/Accident (E/A) and Adverse Reaction (AR) Reporting and Investigation Establishments that have reason to believe an E/A or unexpected AR has occurred must: Determine nature of E/A or AR and identify implicated CTO Notify the source establishment and other establishments from which they received CTO or to which they distributed CTO All establishments must immediately quarantine any implicated CTO in their possession until the source establishment completes an investigation 22

23 E/A, AR Reporting and Investigation Source Establishment must: initiate an investigation without delay notify Health Canada in writing of the investigation if the E/A could lead to serious AR involving an infectious disease, or if an unexpected serious AR potentially involves an infectious disease provide Health Canada with a report within 24 hours, provide updates on steps taken every 30 days and provide a final report upon completion of the investigation, including results of the investigation, final disposition of CTO and corrective actions taken notify other establishments in writing of the results of the investigation Other establishments must provide the source establishment with any relevant information required to conduct the investigation 23

24 Adverse Reaction Reporting Guidance Document for Source Establishments reporting Adverse Reactions to Human Cells, Tissues and Organs Will provide information and instructions for filling out MedEffect Canada forms for reporting Adverse Reactions Canada Vigilance HC/SC 4016 form 24

25 Transitional Provisions Cells and tissues that were processed within five years before the regulations are registered can only be imported and/or distributed by a registered establishment CTO processed prior to the coming into force of the CTO Regulations must meet certain safety requirements, namely that every registered and transplant establishment must ensure that the donor identification code is a component of its record system, and that all establishment records must contain information with respect to all CTO that it processes, distributes, imports or transplants that identifies both the establishment from which it received the CTO, and all establishments to which it will be distributed These provisions will remain in effect for five years 25

26 Finalize Guidance Document Guidance Document for Cell, Tissue and Organ Establishments Cells, Tissues and Organs for Transplantation Comments from initial draft posted on Health Canada website June 2007 are being considered and final document will be posted on the Health Canada website this summer 26

27 Compliance verification of Foreign Source Establishments Foreign source establishments must register with Health Canada certify compliance with the CTO Regulations the CTO product has been declared safe for transplantation Through a Memorandum of Understanding with the US FDA Health Canada is able to obtain information for its inspection and investigation activities If Health Canada has reasons to believe that the safety of cells, tissues or organs has been or could be compromised it has the ability to cancel a foreign establishment's registration number, thereby preventing Canadian importers from importing and using tissue processed by the establishment 27

28 Evaluate regulations Evaluation will be conducted in early 2009 Are the CTO regulations effective? What can be improved? Some areas to evaluate: - Is the standards based approach working to allow faster updating of the regulations as technological changes? - Are risk management & inspection strategies geared to maximize safety while balancing availability and quality of the CTO? - In emergencies are lookback/traceback systems working to identify the source of the risk? 28

29 Important Points to Take Home CTO Regulations came into force on December 7, 2007 Health Canada s authority is over Product Safety and not transplantation Canadian establishments may only import CTO that is processed and determined safe for transplant by an establishment registered with Health Canada The registration application includes a signed statement that the establishment is compliant with the Regulations The Source Establishment is responsible for the processing and for determining whether the CTO are safe for transplantation 29

30 CTO Regulatory Framework Summary & Conclusion In general, the Regulations contain broad goals that are applicable to a wide range of CTO (i.e., specifies what but not how) Establishments have the flexibility to determine how to meet these goals by developing specific requirements for the CTO they process The ultimate goal of the regulatory framework is to balance the need for safe CTO with the need to ensure availability of CTO for transplantation. 30

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