Pre-qualification project for antimalarial medicines

The supply of antimalarial products that are effective and of assured quality has become a major concern at both international and country level. The recent awards of funding to national malaria programmes of a number of countries, some of which are planning to implement the use of new artemisinin-based combination antimalarial products, further indicates a need to identify sources of products of assured quality.

As was commenced for HIV/AIDS medicines in 2001, a Procurement, Quality and Sourcing Project: Access to Artemisinin-based Combination Antimalarial Drugs of Acceptable Quality was started by WHO in collaboration with other UN Organizations, such as UNICEF and UNDP, in April 2002 as part of the Roll Back Malaria project. This project aims to facilitate the procurement of artemisinin-based combination antimalarial medicines of assured quality. The assessment procedure consists of various components including:

- Evaluation of product data and information provided by manufacturers and suppliers, and
- Inspection of manufacturing sites.

This project evaluates pharmaceutical finished dosage forms in the treatment of malaria according to WHO recommended standards of safety, efficacy and quality, and compliance with good manufacturing practices (GMP).

A list of suppliers whose artemisinin-based combination antimalarial medicines have been found acceptable, in principle, for procurement by UN agencies is now available on the WHO web site. As of April 2004, 26 product dossiers for various products and dosage forms from several manufacturers were received and two of these products have been fully assessed and listed as pre-qualified products. The remaining products are currently under review. Interested readers are advised to access the list via the WHO website: http://mednet3.who.int/prequal/.

The survey on sources and prices of selected antimalarial medicines is an information service and not a pre-qualification service. Screening of the products included in this survey has been carried out as indicated in Chapter 1.4. This screening, however, in no way constitutes an active review of product quality. The artemisinin-based combination antimalarial medicines that have been evaluated under the project are marked in Annex IV of this document in bold and with an asterisk (*). Other products listed in this document should, in relation to purchase, be subject to quality assessment review under, e.g. the aforementioned Pre-qualification Project(see WHO Procedure for Assessing the Acceptability, in principle, of pharmaceutical products for purchase by UN organizations, available at: http://med-net3.who.int/prequal/).