WHO Regulators · WHO Blood Regulators Network 2010 11 1. To identify essential control functions that should be undertaken by an effective/functional NRA to assure the quality, safety

WHO Blood Regulators Network 2010 1

WHO Blood Regulators Network

Dr. P. Ganz, Director, Centre for Blood and Tissues Evaluation, BGTD, Health CanadaDr. J. Epstein, Director, Office of Blood Research and Review, CBER, FDA, Chair, BRNDr. R. Seitz, Head, Division of Haematology/Transfusion Medicine, Paul‐Ehrlich‐InstitutDr. G. Smith, Head, Blood and Tissues Unit, TGADr. C. Schärer, Head of Division , Inspectorate, SwissmedicDr. M. Heiden, Section Transfusion Medicine, The Paul‐Ehrlich‐InstitutDr. M. Jutzi, Inspectorate, Swissmedic, SwitzerlandDr. F. Agbanyo, Chief, Blood, Cells , Tissues and Organs Division, CBTE, Health CanadaDr. P. Zorzi, Biological Products Department, Afssaps, FranceDr. I. Sainte Marie, Afssaps, FranceDr. A. Padilla, Quality Assurance and Safety: Blood Products & related Biologicals, WHODr. G. Michaud, Deputy Director, Office of Blood Research and Review, CBER, FDA, USA

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AgendaThe secret of a good presentation is to have a good beginning and a good ending; and to have the two as close together as possible.

“English is the perfect language for Regulators because it allows you to talk until you think of what to say.”

-Garrison Keillor

Assessment Criteria for National Blood Regulatory Systems

BACKGROUNDAs a pillar for safe blood programs globally, WHO has advocated the establishment and sustenance of strong National Regulatory Authorities (NRA) both in developed and developing countries.NRAs and their functions regarding regulatory oversight for blood are an integral component for ensuring safe and high quality blood products and labile components (WHA resolution 63.12).



AN UNMET NEED

Ancillary to the existence of NRAs to regulate activities assuring the provision of safe blood, there is currently an unmet need to develop criteria to benchmark NRAs globally as concerns activities related to regulation of blood



AN UNMET NEED (2)

For both developed and developing countries, a benchmarking or assessment process could serve as a useful means to highlight strengths of NRA programs for regulation of blood and blood products whilst identifying gaps or areas for future development



AN UNMET NEED (3)

While it is recognized that there may be regulatory performance frameworks in place for assessment of regulatory oversight for pharmaceutical drugs in many jurisdictions, these assessment tools may have limited applicability to blood.



Co‐OPERATION/CONVERGENCE AS A GOALIn line with WHA Resolution 63.12 the Assessment Criteria may foster advocacy for governments to work toward establishment of greater standardization amongst regulatory bodies globally in the area of regulation of blood and blood products



PURPOSE & OBJECTIVES


1. To identify essential control functions that should be undertaken by an effective/functional NRA to assure the quality, safety and efficacy of blood and blood products as well as IVDs and associated drugs.

2. To establish standard indicators for these essential functions in order to allow NRAs to assess their performance in the regulation of blood and blood products


EVALUATION TEMPLATES USED TO DEVELOP DRAFT CRITERIA

WHO Pre‐Qualification Assessment Criteria for VaccinesBenchmarking of European Medicines Agencies (BEMA) toolDraft WHO data collection tool for the review of drug regulatory systems


Assessment Criteria for National Blood Regulatory SystemsOVERALL STRUCTURE OF ASSESSMENT TOOL

Focus on the following general areas:Legal framework/authoritiesEssential functionsInfrastructureQuality elements to be defined under each of these headings.


Assessment Criteria for National Blood Regulatory SystemsESSENTIAL FUNCTIONS

National Regulatory SystemNational Regulatory AuthorityLicensing/Registration of Blood EstablishmentsLicensing/Registration of Manufacturers of plasma derived products and WholesalersApproval of Blood, and Blood Components (Product and/or Process Approval


Assessment Criteria for National Blood Regulatory SystemsESSENTIAL FUNCTIONS (2)

Control systems for medical devices including IVD’s and related drugs used in the manufacturing of blood productsControl of clinical trialsMarketing authorization for plasma derived medicinal productsSystem for lot release of plasma derived medicinal products


Assessment Criteria for National Blood Regulatory SystemsESSENTIAL FUNCTIONS (3)

Regulatory Inspections and Enforcement activitiesHaemovigilance and PharmacovigilanceEnsuring Traceability and Record keeping by Manufacturers for all regulated productsInternational co‐operation


WHO Blood Regulators Network 2010

NO TIME WASTED ZONE

With only 1Face to faceMeeting per Year, BRN members had to find extra time to develop the assessment tool.Dr. Epstein kindly shared his home office blueprints.

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Examples of the Assessment Tool







Assessment Criteria for National Blood Regulatory SystemsSPECIAL CONSIDERATIONS IN DEVELOPMENT OF ASSESSMENT CRITERIA

Some essential functions or activities may be applicable regardless of the intended use of blood or blood components (e.g. transfusion or for further manufacturing) while some functions/activities may only specifically apply to blood components


Assessment Criteria for National Blood Regulatory SystemsSPECIAL CONSIDERATIONS IN DEVELOPMENT OF ASSESSMENT CRITERIA (2)

For countries which are importing source material (e.g. Plasma), fewer functions may need to be ensured within the authority of the importing country, although it should ensure that the appropriate regulatory activities are being carried out in the country of manufacture (export)


Assessment Criteria for National Blood Regulatory SystemsSPECIAL CONSIDERATIONS IN DEVELOPMENT OF ASSESSMENT CRITERIA

In some countries, including some BRN member states, all functions related to blood regulation fall under the purview of a single agency which has the full authority in command and control of these functions. However, in other cases, regulatory functions may be assigned to two or more responsible authorities, at either the same or different levels of government.


Assessment Criteria for National Blood Regulatory SystemsCURRENT STATUS OF ASSESSMENT TOOL

Initial drafting of tool by BRN was begun in 2008 and presented to the 13th International Conference for Drug Regulatory Authorities (ICDRA) in Sept 2008.ICDRA endorsed this BRN initiative to finalize the Assessment Criteria for National Blood Regulatory Systems as a tool to enhance blood regulation globallyAdditional work on Regulatory Assessment Criteria by BRN at ECBS and throughout 2009.


Assessment Criteria for National Blood Regulatory SystemsSELF ASSESSMENTS BY HEALTH CANADA AND SWISSMEDIC

Pilot self‐assessments were conducted by Health Canada and Swissmedic in 2009‐2010 for validation

Agreement that key indicators were relevantChanges needed for some sub‐indicators were identifiedHigh level re‐organization of some key indicators and sub‐indicators to improve clarity and continuity A need was identified to develop an ancillary guidance document to aid assessors (or self assessors)


Assessment Criteria for National Blood Regulatory SystemsCURRENT STATUS OF ASSESSMENT TOOL (2)

A final work product was finalized at the BRN meeting on 21 October 2010. The criteria are being shared for comment with participants at this ICDRA meeting.


Assessment Criteria for National Blood Regulatory SystemsNEXT STEPS

Feedback from this meeting regarding the assessment tool is invited, and will be considered by WHO at a future meeting of the BRN. To be considered by the panel at ICDRA is the question: How can these Regulatory Assessment Criteria be used to advance blood regulation in your various jurisdictions?


“Anybody who thinks talk is cheap has never argued with a traffic cop.”-Henny Youngman.


Documents

WHO Regulators · WHO Blood Regulators Network 2010 11 1. To identify essential control functions that should be undertaken by an effective/functional NRA to assure the quality, safety