Prequalification of medicines.

Improving medicines quality through prequalification

WHO, UNICEF and other organizations are involved in the procurement of pharmaceutical products for use in public health programmes, such as those to combat HIV/AIDS, malaria and tuberculosis. Because low-cost pharmaceutical products of assured quality offer the greatest potential for maximizing the impact of efforts to combat such diseases, the quality of pharmaceutical products has become a major concern at both international and country level. Efforts to accelerate access to pharmaceutical products used in the treatment of these major impact diseases through price negotiation and generic competition have highlighted the fundamental importance of developing a robust quality assurance system for pharmaceutical products and diagnostics. Without a quality assurance system, public health agencies risk sourcing substandard, counterfeit and contaminated pharmaceutical products leading to product complaints and recalls, waste of money and health risk to patients.

WHO Prequalification Project

The prequalification project, set up in 2001, is a service provided by the World Health Organization to facilitate access to medicines for HIV/ AIDS, malaria and tuberculosis that meet international standards of quality, safety and efficacy. From the outset, the project was established by WHO, UNAIDS, UNICEF, UNFPA, with the support of the World Bank, as a concrete contribution to the United Nations priority goal of addressing widespread diseases in countries with limited access to quality medicines.

Prequalification by WHO involves assessing data provided by the manufacturer and inspecting sites involved in manufacturing, clinical or bioequivalence testing for compliance with WHO requirements. The coordination of the project, including dossier assessments and site inspections are impartial. Neither the external assessors and inspectors nor the WHO prequalification team are engaged in product procurement, supply, distribution, or policy-making. The manufacturer is responsible for the development of the products and must ensure that a product dossier is submitted and that any sites involved in manufacturing and clinical testing comply with good manufacturing pactice (GMP) , good clinical practice (GCP) and good laboratory practice (GLP). In the event that compliance is not confirmed, the manufacturer will be expected to take corrective action and generate new data as required. If the corrective actions are confirmed as satisfactory by WHO, the product--as manufactured at a particular site--will be included in the WHO list of prequalified products (1).

Achievements and challenges

In May 2004, the World Health Assembly requested measures to strengthen the Prequalification Project and to ensure that the prequalification review process and results of inspections and assessment reports of listed products are made publicly available (2). The Prequalification Project has optimized its resources to avoid any backlog in its pipeline. It now takes around 3-4 months from submission of a dossier to prequalification of the …