Prequalification
Prequalification
In 2001, WHO set up a service, the Prequalification project, to facilitate access to medicines that meet unified standards of quality, safety and efficacy for HIV/AIDS, malaria and tuberculosis commodities. It is an on-going procedure to assess products and manufacturers, focusing on initial assessment (prequalification), on-going monitoring, and re-qualification. It is not intended to replace national regulatory authorities or national authorization systems for importation of medicines. Prequalification draws from the expertise of some of the best national regulatory authorities to provide a list of prequalified products that comply with unified international standards.
More information
- Prequalification Project website
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Pharmaceutical Inspection Co-operation Scheme