Prequalification progress - Vaccines

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


Review of progress


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


100 meetings in 2009 with manufacturers and other stakeholders

31 new vaccine tests available through WHO contracted labs


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


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

Public realm

Private realm

Functions:- Maintain registers- Manage correspondence- Generate catalogue updates- Manage user feedback- Traceability- Institutional memory

A PQS Web based database1. At its final phase of development


1. Published SOPs for all functions2. Guidelines for manufacturers (published 6)3. Performance specifications & Verification

protocols for all product sub-categories4. Information sheets on laboratories5. Product information sheets for all

prequalified products6. Soon online catalogue

1. Online search2. Downloadable3. Printing option

Performance, Quality & SafetyOnline published documentation


1. Increase the number of products by category to ensure fair competition

2. Institute a functional user-feedback system3. Build up on existing active partnerships4. Develop a tool to assist NRAs in strengthening

their role of overseeing the equipment for immunization.

5. Establish a reality check hub for needs assessments and field test of newly developed/introduced devices and equipment.

The way forward ….

Performance, Quality & Safety

Financing of the projectAnnual cost: US$ 500.000Cost recovery US$ 150.000Gap US$ 350.000


Current and future synergies


Synergies with/between countries (1)

Partners(UNICEF, GAVI, BMGF, PATH, manufacturers)

More and faster prequalification of vaccines

Countries• crisis management for vaccine safety events

100% of vaccines used in national immunization programmes are of assured quality by 2013

(SO11 MTSP indicator)

31

7751

1512

13

0102030405060708090

UN Agency Procuring Producing

Achieved Not achieved


Synergies with/between countries (2)

Observed audits Regulatory Mentoring to Strengthen

Capacity – Health Canada/CDSCO India case study Networking

– Developing Country Vaccine Regulator's Network- Developing Country Vaccine Manufacturer's Network

Functionality of NRA's in key developing countries that supply affordable priority

vaccines is sustained and increased


Synergies with countries (3)Policy coherence

Vaccine prequalified

Prequalification process

Expert Committee on Biological Standardization

Global Advisory Committee on Vaccine Safety

WHO policy recommendations (SAGE, vaccine position papers,..) on control of disease through vaccination; schedules for developing countries

Product licensed by

functional NRA

Procurement by UN

Agencies

Industry application

Critical stepInteraction/influence

Functional NRAFunctionalNRA

Global Advisory Committee

on Vaccine Safety Expert Committee on Biological

Standardization


National AEFI surveillance, investigation and response

Immunization programme

AEFI review committee

Other support groups*

Regulatory authority

Global analysis and response

GACVS Other global or regional advisory bodies

Global capacity building and

harmonized tools

WHO and partners**

Brighton Collaboration

CIOMS/WHO working group

Global signal detection and

evaluation

Uppsala Monitoring Centre

Global vaccine safety data link

Other partners**

Product monitoring

Vaccine manufacturersLicensing authorities in

countries of manufacture

Procurement agencies

Synergies with countries (4) Blueprint for a 21st century system for global vaccine safety


Synergies between PQ programmes Joint audits of NRA's (2009)

- Egypt: review and strengthening of components of the regulatory system-Bangladesh: Joint review of Medicines and Vaccines

- Led to joint development plan for support to core activities

Common functions of NRA's (examples)-Marketing authorisation and licensing- Oversight of clinical trials

Internal Working Group- Comparison between the WHO PQ procedures


Challenges


Vaccine prequalification resource gaps

Relative modest budget (capped at 19.3 million$) given scope of work to service all WHO Member States

Funding gap from 2010 onwards (due to sun-setting of some existing grants, plus high dependency on 1 major donor)

Flexible funds are being lost -disproportionately affects core activities, eg normative work

Ways forward: (a) increase awareness of need for flexible funding of critical core functions (b) business plan to be developed

UN Prequalification of Diagnostics, Medicines and Vaccines 5th Consultative Stakeholders Meeting, 11 February 2010

WHO Global Immunization Work, 2010-11 Total budget estimate US$ 260M

(amounts in million US$)

GATES (2010-11), $18, 7%

UNICEF (2010-11), $3, 1%

PATH (2010-11), $8, 3%

CANCIDA (2010), $4, 2%

Others, $7, 3%

Monitoring, other VPDs surveillance, $12, 5%

Multi year planning , $1, 1%

MNT control , $3, 1%

Yellow fever control and surveillance, $7, 3%

Meningitis control and surveillance, $4, 2%

HepatitisB control , $2, 1%

Advocacy, $3, 1%

CDC Foundation (2010-11), $2, 1%

Routine immunization, service strengthening, $19, 7%

Financing and procurement , $4, 1%

Logistics , $6, 2%

Research , $21, 8%

Policy, strategies, advisory bodies ,

$6, 2%

Immunization safety, AEFI, $6, 2%

Funding gap $130, 50%

Standards and regulation , $7, 3%

New vaccines technical support and surveillance , $12, 5%

Measles control and surveillance,$20, 8%

Core and flexible funding (2010-11), $16, 6%

GAVI/ADIP (2010), $36, 14%

US/CDC (2010-11), $35, 13%

Funding Gap Breakdown*

as at November 2009

*The above budget does not include budget and funding gaps for Polio, Measles SIAs, YF and Meningitis campaigns, Influenza

Each category includes specific policies, strategies, planning, capacity building and personnel


Further information

www.who.int/immunizations www.who.int/biologicals

www.who.int/vaccine_safety

http://www.who.int/immunizations

http://www.who.int/immunizations

http://www.who.int/biologicals

http://www.who.int/vaccine_safety


Spare slides


PQS Guidelines for Manufacturers

1. A guideline for manufacturers of waste management equipment, WHO/PQS/E10/GUIDE.1.3

2. A guideline for manufacturers of cold rooms and freezer rooms, WHO/PQS/E01/GUIDE.1.2

3. A guideline for manufacturers of vaccine refrigerators, vaccine freezers and icepack freezers, WHO/PQS/E03/GUIDE.1.2

4. A guideline for manufacturers of solar power systems, WHO/PQS/E03/GUIDE.2.2

5. Guidelines for manufacturers of temperature monitoring devices PQS/E06, WHO/PQS/E06/GUIDE.1.2

6. Prequalification of single-use injection devices under the PQS system: A guideline for manufacturers, WHO/PQS/E08-E13/GUIDE.1.3


PQS categories: progress overview

PQS categories Description Drafted Finalized Published

Pre-qualified products

ProductsUnder review

Manufacture

PQS - E01 Cold rooms and related equipment 14-Sep 07 0 0 3

PQS - E02 Transport. Guidelines to be published

PQS - E03 Refrigerators and freezers. 14-Sep 07 7 16 8

PQS - E04 Cold boxes and vaccine carriers. 8-Dec 08 1 24 9

PQS - E05 Icepacks. 8-Dec 08 0 14 7PQS - E06 Temperature

monitoring devices. 7-Jan 08 9 2 7PQS - E07 Cold chain accessories To be established

PQS - E08 Single use injection devices. ISO 7886 - part 3: 2005 30 0 17

PQS - E09 Steam sterilizers Abolished

PQS - E10 Waste management equipment. SBs 1 May 08 9 0 5

PQS - E10 Waste management equipment. Needle cutters

4-March 09 0 0 0

PQS - E11 Specimen collection equipment. Abolished

PQS - E12

PQS - E13 Therapeutic injection devices. ISO 7886 - part 4: 2006 37 5 8


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


WHO-PDA Pharmaceutical Cold Chain Management on WheelsExperiential learning

New initiatives

2010 course

7-12 June 2010, TURKEY

Berlinger, LogTag, Blowkings, ColdPack


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


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

Regional/C

ountry Offices

From Headquarters

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Prequalification progress - Vaccines

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