WHO Prequalification of Medicines Programme is a service that is provided by WHO to evaluate the quality, safety and effectiveness of drugs. Manufacturers who have undergone a prequalification may participate in the supply of medicines to other countries with limited resources, which is carried out by WHO.
For prequalification, manufacturers must go through five stages:
The activities of the Prequalification Programme are based on international pharmaceutical standards of quality, safety and efficacy of medicines. In the long run, its goal is to increase access to medicines of assured quality by helping manufacturers to ensure compliance with WHO standards and supporting regulatory authorities to comply with them. In addition to evaluation and inspection activities, the Prequalification Programme creates national potential for sustainable production and monitoring of quality medicines by organizing training and transferring direct experience at the country level. The program also provides targeted technical assistance to manufacturers and quality control laboratories.
