PMS of diagnostics - WHO · PMS for prequalified diagnostics - The impact on diagnostics procurement PMS information collected through the performance of the activities described

WHO PMS for diagnostics | 4 February 20091 |

Post-market surveillance of diagnostics: The WHO post-market surveillance

system for diagnostics

Post-market surveillance of diagnostics:

The WHO post-market surveillance

system for diagnostics

Informal Consultative Meeting for Diagnostic Manufacturer Associations, UN Procurement Agencies and WHO4 February 2009, WHO HQ, Geneva

Ms Irena PratDepartment of Essential Health Technologies

Informal Consultative Meeting for Diagnostic Manufacturer Associations, UN Procurement Agencies and WHO4 February 2009, WHO HQ, Geneva

Ms Irena PratDepartment of Essential Health Technologies


Presentation contents Presentation contents

○ Post-market surveillance of diagnostics - introduction

○ Roles of key players in the WHO PMS system for Dx

○ Core activities of the WHO PMS system for Dx

○ Implementation of the WHO PMS programme in resource

limited settings


About post-market surveillance for diagnosticsAbout post-market surveillance for diagnostics

○ International standards requirements on the PMS system

establishment by the manufacturer

○ PMS provides a continuous feedback on the Dx on the

market

○ PMS helps the manufacturer to maintain a high standard of

product quality and customer satisfaction


PMS for prequalified diagnostics:Why is it needed


As a prequalified diagnostic (PQDx) is placed on the market

it is necessary to make sure that:

○ It continues to meet all safety and performance

requirements and standards that were required for the

PQ approval

○ Any problems with the use of the product are dealt with

and reported through appropriate channels

The post-market phase of a Dx is as important as the

assessment and evaluation performed within PQ




A PMS programme has been developed by WHO to:

○ Ensure the ongoing compliance of PQDx with PQ requirements once placed on the market

○ Strengthen National regulatory authorities (NRAs)by providing operational guidance documents and training programs on PMS


Roles of key players in the WHO PMS system for PQ Dx

Roles of key players in the WHO PMS system for PQ Dx

○ Manufacturers maintaining high product quality and

reporting on adverse events

○ NRAs and National reference laboratories (NRLs)

performing PMS activities in the country and providing

feedback on diagnostics performance in the field

○ WHO/EHT/DLT unit ensuring traceability of PQDx and

providing support to manufacturers, end users and NRAs

facing problems with PQDx

○ End users identifying problems with Dx


Core activities of the WHO post-market surveillance system for diagnostics


The WHO PMS system for PQDx comprises two main

components:

○ Proactive surveillance activities allowing collection of

information on quality, safety and performance of the Dx

after it has been placed on the market

○ A reactive vigilance system for the notification and

evaluation of adverse events involving PQDx




The WHO PMS system for PQ Dx is implemented through the

performance of three core activities:

PMS for PQDx

Proactive component Reactive component

(3) The vigilance

system

(1) Batch release

testing(2) Sampling and testing

of samples from the field


Batch release testingBatch release testing

Reasons for batch release testing:

○ Difference in quality between batches of the same diagnostic may occur

○ Inappropriate transport and storage conditions (temperature, humidity, exposure to sunlight…) may affect diagnostic's performance

○ A high level of reliability can only be guaranteed through testing of each batch procured in a country



Purpose of batch release testing:

○ Ensure that the Dx delivered meet the PQ requirements

and that the manufacturer's claims on product's

performance stand up as the Dx is procured to a Member

State

○ Ensure that only batches with satisfactory test results are

distributed to laboratories all over the country.



Batch release testing procedure:

○ Batch release sampling of each incoming delivery of PQ Dx

in a Member State for independent laboratory analysis in

the NRL

○ Analysis of compliance with the product's specifications

using the WHO evaluation panel of well-characterized

specimens

○ Manufacturer's package insert followed


Testing of samples from the filedTesting of samples from the filed

Reasons for sampling and testing of samples form the filed:

○ Inappropriate transport (temperature, humidity, exposure to sunlight…) after procurement of the assays to the country may affect the assay's performance when used in the field

○ Inappropriate storage conditions after procurement of the assays to the country may affect the assay's performance when used in the field



Purpose of sampling and testing of samples form the filed:

○ Get an oversight of the performance of the tests sampled in laboratories at different levels within the country

○ Testing of samples from the field in combination with batch release testing guarantees the monitoring of assay quality throughout the distribution chain



Sampling and testing of samples from the field

procedure:

○ Samples of PQ Dx are taken in different laboratories twice

per year for independent laboratory analysis in the NRL

○ Analysis of compliance with the product's specifications

using the WHO evaluation panel of well-characterized

specimens

○ Manufacturer's package insert followed


The vigilance systemThe vigilance system

WHO has adopted an internationally accepted approach to the vigilance system developed by the GHTF and adapted it for the needs of the WHO PQDx PMS system

Purpose of the vigilance system for PQDx:

○ Ensure traceability of information on PQDx

○ Enable coordinated action in countries where PQDx are supplied



The vigilance procedure:

○ Vigilance notifications submitted to WHO will be

evaluated

○ Manufacturer's investigation will be monitored

○ Information exchange might be undertaken with NRAs

Reporting forms for manufacturers, end users and NRAs and

instructions for fulfilment of these forms are being

developed for vigilance data exchange with WHO



The vigilance system for PQDx will be developed at two

levels:

○ Vigilance data on PQDx will be centrally collected and

evaluated by WHO (short-term)

○ Guidance documents and training programs will help

countries frame policies on vigilance procedures at

national level (long-term)


PMS for prequalified diagnostics -The impact on diagnostics procurement

PMS for prequalified diagnostics -The impact on diagnostics procurement

PMS information collected through the performance of the

activities described will ensure that only PQDx that

continue to meet prequalification criteria once put on the

market will be used in countries

Unsatisfactory PMS data will be dealt with in cooperation with

the manufacturer and the NRAs concerned


Implementation of the WHO post-market surveillance programme in resource limited settings


Main constraints:

○ Lack of feedback on Dx performance in the field

○ Lack of regulatory framework for performing PMS activities

○ Regulatory capacities limitations

○ Poor manufacturers and end users reporting habits




WHO's response to countries needs:

○ Guidance documents giving recommendations on how to

set up and implement a PMS system

○ Training programs to accelerate the implementation

○ PMS Pilot project to gain experience from the field




The PMS system will be first launched as pilot project in 5

countries

Feedback information on how the PMS system stands up

when implemented in pilot countries

Experience gained from the pilot project will be used as basis

for possible improvement of the PMS system launched in

pilot countries


Thank you

Documents

PMS of diagnostics - WHO · PMS for prequalified diagnostics - The impact on diagnostics procurement PMS information collected through the performance of the activities described