Contributions to Millennium Development Goals
MDGs requiring support in the areas of in vitro diagnostics and laboratory services
Progress towards achieving the Millennium Development Goals to reduce morbidity and mortality related to HIV/AIDS, malaria and other major diseases has been slow, partly because of lack of access to quality medicines and appropriate health technologies, in particular in vitro diagnostics and laboratory services. Antiretroviral therapy, tuberculosis treatment and anti-malarial therapy are becoming increasingly available in many resource-limited settings as a result of global efforts, however, the same attention has not been given to the provision of appropriate and affordable in vitro diagnostics.
The Millennium Development Goals cannot be reached unless the HIV status of more individuals in resource-limited settings can be diagnosed. Without diagnostic tools, safe and effective drug treatment, prevention of resistance to antiretroviral therapy and monitoring of resistance are not possible.
The Prequalification team - Diagnostics provides countries with the appropriate technical support, tools and guidance on the provision of in vitro diagnostics and laboratory services in ways which strengthen health systems consistent with the values of Primary Health Care.
- EBOLA IVDs
- WHO list of prequalified in vitro diagnostic products
- Status of active applications to the prequalification of in vitro diagnostics
- Complaints and Product Alerts
- Streamlining of the Prequalification of Diagnostics
- WHO Prequalification of Male Circumcision Devices
- Procurement of in vitro diagnostics
- HIV incidence assay working group
- Information resources
Invitation to manufacturers of in vitro diagnostics for Zika virus to submit an application for emergency use assessment and listing by WHO
ZIKA VIRUS: Emergency Use Assessment and Listing Procedure (EUAL) announcement
- Sample product dossier for an IVD intended for HIV self-testing (for public comments to be submitted to firstname.lastname@example.org no later than 29 February 2016)
- New Guidance for Manufacturers (TGS 1 & TGS 2) (for public comments to be submitted to email@example.com no later than 29 February 2016)
Newsletter Issue 12, Q4 2015
Guidance for post-market surveillance
Prioritization criteria expanded to HPV