Post-Market Surveillance of Diagnostics

1. Post-Market Surveillance of Diagnostics XVII International AIDS Conference4 August 2008, Mexico CityMs Anita SandsDiagnostics & Laboratory Technology TeamDepartment of Essential Health Technologies

2. Prequalification of Diagnostics Programme • The WHO Prequalification of Diagnostics programme has 4 components: • Application to the programme and a dossier review • Inspection of the manufacturing site to assess the QMS • Laboratory evaluation to assess performance and operational characteristics of the product • Building of regulatory capacities, including post-market surveillance of diagnostics • Post-market surveillance (PMS) is thus the fourth pillar of the prequalification process

3. About Post-Market Surveillance • PMS provides a continuous feedback about the product & helps the manufacturer to maintain a high standard of product quality & customer satisfaction • Prequalification is an assessment done at a point in time (pre-market entry), whereas PMS contributes to understanding if the manufacturer is capable of consistently producing good quality product & consistently able to get that product to countries in good condition.

4. PMS for Diagnostics – Why is it needed • After a product is placed on the market, it is necessary to make sure that: • It continues to meet all safety and performance requirements that were verified as part of PQ process • Any problems with the use of the product are dealt with and reported through appropriate channels • PMS ensure the ongoing compliance with prequalification requirements once placed on the market

5. Roles of the Countries and Manufacturers • Strengthen National Regulatory Authorities (NRAs) for diagnostics • By providing guidance & training on PMS • NRAs need to monitor & ensure traceability of information on diagnostic products • Manufacturers of PQDx have the responsibility to implement & effect their own PMS system to ensure that any risk associated with the use of their product once marketed is identified early, reported & acted upon.

6. PMS for Diagnostics The WHO PMS system is implemented through the performance of three core activities:

7. Batch release testing • Reasons for batch release testing: • Difference in quality between batches of the same product may occur • Inappropriate transport and storage conditions (temperature, humidity, exposure to sunlight…) may affect a product's performance • To ensure the quality of product in country before it is distributed to all testing facilities within that country. • Purpose of batch release testing: • Ensure that the products delivered meet criteria for quality & performance • Ensure that only batches with satisfactory results are distributed to testing facilities all over the country.

8. Batch release testing • Batch release testing procedure: • Upon receipt at the central purchasing body of the country, each incoming delivery of batch should be submitted to testing at the NRL or another identified body. • A representative sample of the batch should be taken for analysis of compliance with the product's specifications • The evaluation is carried out using a panel of well-characterized local specimens (batch release panel) • The assay is performed exactly according to the manufacturer's instructions (package insert)

9. Sampling and testing of test kits from the field • Reasons for sampling and testing of test kits from the field: • Inappropriate transport and storage conditions (temperature, humidity, exposure to sunlight…) during & after delivery of product to the testing facility may affect performance in the field • Purpose of such testing: • Get an oversight of the performance of the product sampled from testing facilities at different levels within the country, gives additional information on the quality of the product at the level of end user • Testing of samples from the field, in combination with batch release testing, ensures that product quality is monitored throughout the distribution chain, thus ensuring that only quality products are used by end users

10. Sampling and testing of test kits from the field • Sampling and testing of test kits from the field procedure: • Samples of product should be taken twice per year for independent laboratory analysis (at the NRL) of compliance with the product's specifications • A sample of test kits from the same batch should be taken from laboratories at different levels • The evaluation is carried out using the batch release panel • The assay is performed exactly according to the manufacturer's instructions (package insert)

11. Vigilance • WHO has adopted an internationally accepted approach to the vigilance system developed by the GHTF (GHTF/SG2/N54R8:2006) & adapted it for the needs of countries • Purpose of the vigilance system: • Ensure traceability of information on products • Enable coordinated action in countries where products are supplied • The vigilance system will be developed at two levels: • Vigilance data on products will be centrally collected, assessed & distributed (short-term) • Guidance documents & training will help countries frame policies on vigilance procedures at national level (long-term)

12. Vigilance • The vigilance procedure: • Vigilance notifications submitted will be assessed • Manufacturer's investigation will be monitored • Information exchange will be undertaken with all interested parties • Standardised reporting forms for manufacturers, end users and NRAs have been developed for vigilance

13. PMS for Diagnostics -The impact on procurement • If there is an alert, those involved will be in a position to anticipate & therefore reduce problems associated with procurement of certain products in countries • Unsatisfactory PMS data will be dealt with in cooperation with the manufacturer and the NRAs concerned • In rare cases, removal from the list of prequalified diagnostics will be undertaken, if necessary, to protect public health

14. PMS Implementation • Main constraints to implementation of PMS identified in resource-limited settings: • Lack of feedback on diagnostics performance in the field • Lack of regulatory framework & capacity for performing PMS activities • Poor reporting habits by manufacturers & by end users

15. Pilot Project of PMS • WHO, in collaboration with CDC & other partners, will pilot a system of PMS in 5 countries. • It is intended to foster collaboration between NRLs and NRAs • Will lead to an overall increased confidence in products used in country • This is vital for national programmes & those parties (both national and international) involved in procurement.

16. Thank you