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

PRIORITIZATION CRITERIA EXPANDED TO HPV

Newsletter Issue 12, Q4 2015

Newsletter Issue 11, Q3 2015

Newsletter Issue 10, Q2 2015

ESSENTIAL MEDICINES AND HEALTH PRODUCTS



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