In vitro diagnostics and laboratory technology

Prequalification of in vitro diagnostics

Role of WHO Prequalification Team - Diagnostics

1. Promote and facilitate access to safe, reliable and appropriate in vitro diagnostic technologies and laboratory services in an equitable manner through:

  • Prequalification of in vitro diagnostics for high burden diseases;
  • Capacity building of national regulatory authorities and national reference laboratories;
  • Facilitation of procurement of affordable and appropriate in vitro diagnostics;
  • Policy, guidance and advocacy to Member States;
  • Provision of quality assurance programmes to countries;
  • Training and technical support including country projects.

2. Support two of WHO's six core functions:

  • setting norms and standards and promoting and monitoring their implementation
  • providing technical support, catalysing change & building sustainable institutional capacity

3. Contribute to achieving three of WHO's impact goals:

  • reduce under-five mortality
  • reduce maternal mortality
  • reduce the number of people dying from AIDS, tuberculosis and malaria

PQ UPDATE

Newsletter Issue 10, Q2 2015

2014 was a year of change and new challenges for WHO prequalification of in vitro diagnostics (IVDs). Following internal and external consultations with stakeholders and funders, it was reorganized and its processes revised in order to better serve its customers, namely WHO Member States, funding, procurement and other UN agencies. This enabled the pipeline to be cleared and timelines to prequalification to be reduced. Success is demonstrated by the rapidly growing list of prequalified diagnostics.

Highlights

  • Newsletter Issue 10, Q2 2015
    pdf, 490kb

    This issue includes the new streamlined approach, abbreviated procedure, intersted in Ebola? Find our what the WHO PQ Dx team has been doing the field of Ebola Virus Disease (EVD) IVDs.

Events

  • HOLD THE DATE!
    The 2015 Joint WHO-UNICEF-UNFPA meeting with pharmaceutical and diagnostics manufacturers and suppliers will be held in Copenhagen during the week of 23-27 November
  • View all events

Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
(HIS/EMP/RHT/PQT)
World Health Organization
20 Avenue Appia
1211, Geneva 27
Switzerland
diagnostics@who.int