QCLs in surveillance and testing for regulatory and prequalification decisions
Once health products have received regulatory approval and are allowed on the market their quality needs to be monitored over time. Also, countries need to be vigilant to assure that all health products available in their jurisdiction are of acceptable quality. Although manufacturers of health products are required to conduct post market surveillance activities and are obliged to report any issues to the national regulatory authority, in practice however, this is often not the case. Therefore, LNS tries to establish the extent of Post Market Quality Surveillance activities for medicines in countries and conducts on a risk-based approach targeted testing of prequalified vaccines.
PMS activities for medicines include to:
- Determine the level of data mining/analysis of PMS laboratory test results.
- Ascertain how data analysis shapes current and future PMS activities
- Establish a system to enable ongoing data collection for PMS laboratory test results.
- Establish a regional database on quality of medicines.
- Develop a data analysis and sharing platform for PMS test results.
PMS activities for vaccines focusses on:
Targeted testing of prequalified vaccines
- Annually a selection of prequalified vaccines is conducted on a risk-based approach
- Usually two to three lots close to their expiry dates are chosen for testing
- Testing is carried out by one independent contract laboratory
The WHO PMS testing outcome is reported to stakeholders and donors (only anonymized data)
Post market surveillance of prequalified in-vitro diagnostics
Guidance documents and activities on post market surveillance of in-vitro diagnostics are carried out by the ISF team and can be found on the following webpages.
