Annual Report 2013: Prequalification of Medicines: A Vital Service
(2014; 28 pages)

Abstract

In 2013 the WHO Prequalification Team: medicines (PQTm) enjoyed many successes: it prequalified its first medicine for a neglected tropical disease, accepted the first semi-synthetic source of artemisinin, a critical ingredient for antimalarials, and achieved its best-ever timelines for prequalification of finished pharmaceutical products.

Not surprisingly, given the experience it has amassed in evaluating medicines quality, WHO’s Member States increasingly seek PQTm’s support and guidance with respect to selection, importation and manufacture of quality-assured essential medicines. Manufacturers and product development partnerships, such as the Medicines Patent Pool and DNDi, are also becoming more reliant on PQTm’s advice at the early product development stage, to accelerate market entry and patient access. Thus a programme born as a qualityassurance service for UN procurers 13 years ago has evolved into a global “platform” where regulators and manufacturers learn to work together, according to internationally recognized, harmonized quality standards.

 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: October 29, 2018