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


New financing model for WHO Prequalification and supporting regulatory functions

10 April 2015 -- A new funding model, use of the funds raised and timelines for implementation, before proceeding with implementation, however, WHO is seeking additional input by 3 May 2015 ― via questionnaire ― in order to assess whether any of the parameters of the model require adjustment.



    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
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Contact us

Prequalification Team - Diagnostics
Regulation of Medicines and other Health Technologies
Department of Essential Medicines and Health Products
World Health Organization
20 Avenue Appia
1211, Geneva 27