UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting, 11 February 2010 Prequalification progress - Vaccines Dr David Wood, Coordinator, Quality Safety and Standards (QSS), Department of Immunization, Vaccines and Biologicals (IVB)
Prequalification progress - Vaccines. Dr David Wood, Coordinator, Quality Safety and Standards (QSS), Department of Immunization, Vaccines and Biologicals (IVB) . Outline. Review of progress Current and future synergies . Review of progress. Vaccines prequalified by WHO: Status 2010 - PowerPoint PPT Presentation
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UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting, 11 February 2010
Prequalification progress - Vaccines
Dr David Wood, Coordinator, Quality Safety and Standards (QSS), Department of Immunization, Vaccines and Biologicals (IVB)
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
Outline Review of progress
Current and future synergies
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
Review of progress
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
Vaccines prequalified by WHO: Status 2010(assured quality)
used in 124
countries
64% total populati
on
106 pre-qualified
vaccines
24 manufacturer
s
7 emerging economy
country mfrs
15 industrialized country mfrs
Brazil Bulgaria Cuba India Indonesia Russia Senegal
Australia Belgium Canada Denmark France The Netherlands Germany Hungary Italy Japan Rep. of Korea Switzerland
Sweden United Kingdom USA
36 Sites
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
100 meetings in 2009 with manufacturers and other stakeholders
31 new vaccine tests available through WHO contracted labs
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
Revision of vaccines PQ procedure The vaccines prequalification
procedure (WHO/IVB/05.19) was last revised in 2005
WHO plans to update the vaccines prequalification procedure in 2010 to take into account technical, communication and policy revisions
The revision process is described in a concept paper available to meeting participants
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
Prequalification of immunization related equipment – the Performance, Quality & Safety (PQS) scheme
1. Identify requirements & develop and maintain performance specifications and verification protocols.
2. Pre-qualify products and accredit test laboratories3. Monitor products post-market & Prospect innovations
1. Secretariat hosted at WHO2. Inter-agencies and intersectoral
Steering Committee 3. Ad hoc working groups according to
categories4. Involvement of experts from: industry,
laboratories, standard bodies, institutions, freelance experts.
A defined scope - 3 functions
A structured organization
PQS website
Companyregister
Laboratoryregister
PQS Secretariat
PQS database
End users
Documentmanagement
Productregister
User feedback
Functions:- Browse current catalogue- Download PDF catalogue- Print PDF catalogue- Do criteria searches- Browse on-line guides- Submit product feedback
PQS - E13 Therapeutic injection devices. ISO 7886 - part 4: 2006 37 5 8
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
Landscape analysis of regulatoryoversight on PQS items GuidelinesUnited Kingdom, AustraliaTunisia, Senegal?, Thailand/Indonesia, Bolivia?
Regulatory oversight on the management of time and temperature sensitive pharmaceutical products Harmonized guidelines
New initiatives
2008ECBS
2009ECBSECSPP
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
WHO-PDA Pharmaceutical Cold Chain Management on WheelsExperiential learning
New initiatives
2010 course
7-12 June 2010, TURKEY
Berlinger, LogTag, Blowkings, ColdPack
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
Prequalification – vaccines model
Functional National R
egulatory A
uthority
Prequalification
by WHO for UN
List of products of
assured quality
Procure by UN agencies(UNICEF SD; PAHO RF)
Self-procurementby countries
Global supplybase
for a product
UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting,11 February 2010
WHO activities that support vaccine, and related equipment, prequalification
Norms and Standards for Biologicals (Knezevic) REGULATORY BENCHMARKS
New or replacement standards established through ECBSPromotion and implementation of WHO standards
Vaccine Quality and Regulation (Dellepiane)REGULATORY SUPPORT
Strengthen regulatory systems for vaccinesDevelop and promote new regulatory pathways for priority vaccinesEfficient prequalification of vaccines and immunization equipment
Global Vaccine Safety (Zuber)REGULATORY RESPONSE
Global Advisory Committee on Vaccine Safety (GACVS)Strengthened global capacity to monitor and manage AEFIsAssessment of and response to global vaccine safety issues