Gross O
Organisation mondiale de la santé, 20 Avenue Appia, CH - 1211 Geneva 27, Suisse.
Med Trop (Mars). 2006 Dec;66(6):549-51.
Partnered with UNICEF, UNAIDS and the UN Population Fund, and receiving support from the World Bank, the WHO Prequalification Programme provides a solid, scientific assessment of the quality of both generic and patented medicines, based on internationally harmonized standards for evaluating information on product quality and bioequivalence, inspecting manufacturing sites, and undertaking quality control of pharmaceutical production. Agencies and organizations who procure medicines can be assured that products prequalified by WHO are of proven quality and that they do not themselves have to test these products. The WHO list of prequalified products also means that agencies procuring medicines can choose between several manufacturers offering the same quality product, which offers scope for negotiating lower prices. As a result of this Programme, capacity to manufacture generic products of assured quality is increasing, as is capacity to monitor that quality. Initially focusing on medicines for HIV/AIDS, TB and malaria, the Programme is now being expanded to also cover medicines for reproductive health.
与世卫组织预认证规划合作的有联合国儿童基金会、联合国艾滋病规划署和联合国人口基金，该规划还得到世界银行的支持。它依据国际统一标准，对仿制药和专利药的质量进行可靠、科学的评估，这些标准涉及评估产品质量和生物等效性信息、检查生产场地以及对药品生产进行质量控制。采购药品的机构和组织可以放心，经世卫组织预认证的产品质量已得到验证，它们无需自行对这些产品进行检测。世卫组织的预认证产品清单还意味着，采购药品的机构可以在几家提供同等质量产品的制造商之间进行选择，这为谈判降低价格提供了空间。由于该规划的实施，生产质量可靠的仿制药的能力以及监测该质量的能力都在不断提高。该规划最初侧重于用于治疗艾滋病毒/艾滋病、结核病和疟疾的药物，目前正在扩大范围，以涵盖生殖健康药物。
