title: Microbicides from a regulatory perspective.
abstract: 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.
  
  
  RESULTS
  These efforts have significantly clarified the scientific basis for developing regulatory guidance for microbicide development and licensure.
  
  
  CONCLUSIONS
  The technical consultations organised by WHO and others have substantially expanded regulatory perspectives about the development and testing of topical microbicides for preventing the sexual transmission of HIV and other STIs.
authors.affiliation: aMedical Scientific Advisory Services Limited, London, UK bAVAC (Global Advocacy for HIV Prevention), New York, New York, USA cDepartment of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.
authors.forename: Alan B
authors.initials: AB
authors.lastname: Stone
authors.forename: Polly F
authors.initials: PF
authors.lastname: Harrison
authors.forename: Manjula
authors.initials: M
authors.lastname: Lusti-Narasimhan
mesh_terms: D000287:Administration, Topical; D000890:Anti-Infective Agents / Q000627:therapeutic use*; D018890:Chemoprevention / Q000379:methods*; D017277:Drug Approval; D055808:Drug Discovery; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans
chemical_list: D000890:Anti-Infective Agents