PROMOTING THE QUALIT Y OF MEDICINES

This effort aims to expedite the process of prequalification with the World Health Organization (WHO) and expand the pool of viable manufacturers. USP provides technical assistance to interested companies at no cost to the manufacturer on preparing medicines dossiers, evaluating manufacturing practices, providing gap analysis, and guiding them through the facility inspection process. The WHO Prequalification Programme was initially developed to ensure that medicines procured by UN agencies meet international standards of quality, safety, and efficacy. The programme establishes a "List of Prequalified Medicinal Products" from which UN agencies can safely choose, and other organizations purchasing medicines in bulk can use for guidance. Currently, there are not enough WHO-prequalified second-line TB medicines manufacturers or a sufficient supply of products to treat patients with multidrug-resistant TB (MDR-TB). To address this issue, UN procurement agencies, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and many other international and nongovernmental organizations (NGOs) mandate that only medicines prequalified by WHO, or approved by stringent regulatory agencies, are suitable for procurement. A manufacturer's WHO-prequalified medicine is considered acceptable for procurement by UN organizations, such as UNICEF and UNITAID. Other organizations use the "prequalified list" to guide their procurement decisions. Consequently, manufacturers of prequalified products may be invited by UN agencies, WHO member states, or NGOs to submit tenders for a bulk supply of their product. More countries are now recognizing the need for quality assurance in medicines manufacturing and are moving toward more stringent control in procurement and importation. USP plays a supporting role to interested manufacturers by working collaboratively with them to prepare their product dossier for submission to the WHO Prequalification Programme. This involves facilitating discussions with WHO to remedy incomplete dossiers or respond to WHO comments, and guiding a company on-site to comply with the principles and guidelines of WHO Good Manufacturing Practices (GMP). USP also reviews product dossiers for completeness, consistency, and credibility, and determines whether the information fulfills the WHO assessment criteria. Manufacturers that wish to receive technical assistance from USP may submit their Expressions of Interest to the WHO Prequalification team on specific products, including amikacin, capreomycin, cycloserine, ethionamide, kanamycin, levofloxacin, moxifloxacin, ofloxacin, para-aminosalicylic acid (PAS), prothionamide, and terizidone. Once the GDF has authorized a manufacturer to receive technical assistance, USP will review their product dossier(s) for completeness, consistency, and credibility, and determine whether the information fulfills the WHO assessment criteria. Working with USP does not guarantee WHO prequalification status for any medicine, but it offers manufacturers the opportunity to initially present a stronger, higher-quality dossier. USP provides the necessary resources to complement the WHO Prequalification Programme, including assessing preliminary dossiers, conducting GMP inspections, and testing samples for quality. The stronger the dossier, the more quickly and smoothly it will be processed by the WHO prequalification team.