WHO Medicines Prequalification Guidance

Many of the guidance documents approved by the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP) are of significant interest and value for manufacturers. But the ECSPP approval process can be lengthy. To be able to respond promptly to demands for new products or for new formulations of existing products, or to incorporate recent pharmaceutical technology developments in their manufacturing processes, manufacturers often require guidance within a much shorter timeframe.

The WHO Prequalification Team therefore works closely and intensively with pharmaceutical experts to develop guidance, as needed, and promptly. In so doing it both facilitates and eases the technical burden associated with quality medicines manufacturer, and expands the range of appropriate products for meeting treatment needs. Moreover, much of the guidance so developed ― together with feedback from manufacturers and regulators ― forms the basis of guidance documents submitted to ECSPP, thereby also facilitating ECSPP processes.

WHO prequalification guidance documents, application forms and templates are listed below. (Date of issue is given in brackets.) Applicants are also advised to consult these and the guidance documents approved by ECSPP.