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Regulatory Focus™ > News Articles > 7 > Essential IVDs: WHO Preps for Launch of Second Edition List

Essential IVDs: WHO Preps for Launch of Second Edition List

Posted 24 July 2018 | By Zachary Brennan 

Essential IVDs: WHO Preps for Launch of Second Edition List

Following the May launch of its first list of essential in vitro diagnostics (IVDs), the World Health Organization (WHO) is now soliciting applications for including new diagnostic test categories for future iterations of the essential diagnostic list (EDL).

The first edition catalogued the 113 most critical categories of diagnostics for common and priority diseases, and was based on WHO guidelines for hepatitis, HIV, malaria, tuberculosis, syphilis and HPV.

“Like the established Essential Medicines List (EML), the EDL is intended to provide evidence-based guidance, and set a reference for the development or update of national lists of essential in vitro diagnostic tests,” WHO explained.

Applications for inclusion of diagnostic test categories in the second version of the EDL can be submitted by, or through, relevant department(s) within WHO, by WHO regional or country offices, and by other stakeholders, such as academia, NGOs or member states, companies in the IVD industry and IVD industry associations, WHO said. 

“The EDL will be updated/expanded once a year based on yearly calls for submission of applications,” WHO said, noting that as explained in detail in the process document, the application is a two-step process. Full applications will be posted on WHO’s website under selection and use of in vitro diagnostics.

Meanwhile, the WHO is also soliciting applications for nominations for its new Strategic Advisory Group of Experts on In Vitro Diagnostics (SAGE IVD), which oversees the process for updating the list of essential IVDs. 

The SAGE IVD held its first meeting from 16 April to 20 April at WHO headquarters in Geneva. The objectives of the meeting were to define the methods and the work of SAGE IVD, to make recommendations on the development of a model EDL, and on prioritization for eligibility for WHO Prequalification of in vitro diagnostics.

In addition, WHO has now published its "Report of the Third WHO Global Forum on Medical Devices," which took place in Geneva in May 2017. The fourth WHO Global Forum on Medical Device (4GFMD) will take place from the 13 to 15 December 2018 in India.

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