Microbicides from a regulatory perspective.

Objective: To provide researchers, product sponsors, drug regulators, and funding organizations with a convenient reference regarding regulatory guidance for microbicide development and licensure.

Methods: WHO and other leading agencies in the microbicide field sponsored a series of technical consultations over the past decade that engaged a wide range of international experts in regional settings of primary relevance for microbicide development, testing, and eventual use. This article summarizes the results of those consultations against the ever-changing background of HIV prevention.