Changes to the European Regulatory Guidelines for the Approval of Antiretroviral Agents

Abstract

In November 1997, the Committee for Proprietary Medicinal Products (CPMP) amended its points to consider document, which provides licensing criteria for approval of antiretroviral agents, under exceptional and nonexceptional circumstances, in the European Union. The revised guidelines, which are similar to those of the United States Food and Drug Administration, permit the use of short-term plasma HIV-1 RNA data for approval under exceptional circumstances, and data demonstrating the durability of surrogate marker response, consistent with CD4 cell response, for unconditional licensing. These revisions followed a meeting of the Antiviral Ad Hoc Group at which data demonstrating a correlation between reduction in viral load, increase in CD4 cell counts, and clinical benefit were presented.