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Regulatory agencies

Regulatory agencies

Since its inception, regulatory agencies have both supported WHO prequalification of in vitro diagnostics (IVDs) and male circumcision devices (MCDs), and benefited from it. They constitute an important community that joins forces with WHO to help make quality priority IVDs and MCDs available for those who urgently need them.

Regulatory agencies of low- and middle-income (LMIC) countries

For regulatory agencies of low- and middle-income countries (LMICs), WHO prequalification is a source of learning and training opportunities. These include:

  • the opportunity to work with WHO as a rotational assessor or inspector
  • participation in training workshops and working groups on prequalification requirements and current regulatory issues of relevance to prequalification and regulation of IVDs and MCDs
  • participation in the WHO Collaborative Procedure for Accelerated Registration.

Usefulness of WHO technical outputs of IVD and MCD prequalification

The most useful sections on this website for regulators are:

  • Procedures and Fees for IVD Prequalification and Procedures and Fees for MCD Prequalification ― presenting all the requirements that must be met for prequalification of an IVD or MCD
  • IVDs Under Assessment and MCDs Under Assessment ― summarize what products are currently under assessment
  • WHO List of Prequalified IVDs and WHO List of Prequalifed MCDs ― giving details of IVDs and MCDs that have been prequalified, including applicant and manufacturing site details
  • Prequalification Reports ― WHO Public Assessment Reports describe the products that have been prequalified and WHO Public Inspection Reports describe the manufacturing sites that have passed WHO inspection
  • Guidance Documents ― three types of guidance are available: WHO prequalification guidance (including sample dossiers); the WHO Technical Specifications Series and the WHO Technical Guidance Series
  • Collaborative Procedure for Accelerated Registration ― describing an innovative WHO procedure that offers regulators the opportunity to optimize use of their human and financial resources, as well as enhance assessment expertise
  • Risk–benefit Assessment [Emergency Use Listing Procedure (EUL), and the Expert Review Panel for Diagnostics (ERPD)] ― describing procedures other than prequalification for assessing products and which can facilitate access to urgently-needed products for which no or an insufficient number of prequalified or stringently-approved products are available
  • Key Contacts — the key persons who can be contacted regarding different aspects of prequalification, or collaborative registration or technical assistance.

For all regulators, the Notices of Concern or Suspension issued by WHO are an important source of information, alerting them to quality issues relating to specific IVDs or MCDs, that may have entered or could enter their markets.