Regulatory issues in microbicide development
The development of microbicides that individuals can apply vaginally or rectally to protect against infection with HIV and other sexually transmitted pathogens is the aim of intensive research being pursued in many countries. One of the numerous challenges that the microbicide field has had to face is a lack of clarity about regulatory requirements for product development and licensure. In response to this, the World Health Organization (WHO), in collaboration with other leading agencies in the field, and with the support of many international experts, launched a series of technical consultations (Annexes 1 and 2), whose aims were to review microbicide science, identify minimal regulatory requirements and explore ways of strengthening regulatory capacity in low-income countries. The present document draws on the reports of those consultations and other discussions.