Prequalification Team – Diagnostics

SAMPLE PRODUCT DOSSIER for WHO Prequalification: Simu POC CD4 System, THE Manufacturing Company 2014, 114 pages PQDx_170, available at www.who.int/prequalification This sample product dossier has been developed to support manufacturers of point-of care CD4 technology who may have limited experience in compiling a product dossier. It will also be informative for researchers and developers of innovative POC technologies: a good understanding of the types of information and study data required for WHO prequalification and/or regulatory approvals improves the efficiency of both product development and the assessment processes undertaken following submission for national registration or WHO prequalification. This sample dossier is entirely fictitious, and has been produced for illustrative purposes only. It follows the structure of a real-life dossier, providing extensive information about a fictitious diagnostic, the Simu POC CD4 System, and its fictitious manufacturer, THE Manufacturing Company, including: • the WHO product checklist • the product, including regulatory versions and descriptions of variants, the Essential Principle (EP) checklist, and risk analysis and control summary • design and manufacturing information • product performance specification, and associated validation and verification studies • labelling • commercial and regulatory history • quality management system. Although this sample dossier focuses on a POC CD4 technology, much of it will also be of relevance to manufacturers of other priority diagnostics, such as POC HIV viral load or HIV early infant diagnosis, since regulatory requirements for them are very similar. The aim of innovative, quality-assured POC technologies is effective prevention, diagnosis, and treatment of high-burden diseases, such as HIV/AIDS, hepatitis, malaria and tuberculosis. This sample dossier will contribute to speeding up the timescale within which they are made accessible to the populations who need them. WHO welcomes suggestions and comments on this first version of the sample product dossier at diagnostics@who.int, with the aim to printing the final revised version Q3 2014.

WHO wishes to thank UNITAID for its financial support.