title: The value and benefits of the International Conference on Harmonisation to drug regulatory authorities: advancing harmonization for better public health.
abstract: The International Conference on Harmonisation (ICH) is an unparalleled undertaking, which has brought together drug regulatory authorities and pharmaceutical trade associations from Europe, Japan, and the United States, to discuss the scientific and technical aspects of medical product registration. Launched in 1990, the value and benefits of ICH to regulators are being realized. ICH has harmonized submission requirements and created a harmonized submission format that is relieving both companies and regulatory authorities of the burdens of assembling and reviewing separate submissions for each region. As more countries embrace ICH guidelines, we anticipate additional benefits, including the promotion of good review practices and, ultimately, a common regulatory language that will facilitate further interactions among global drug regulatory authorities.
authors.affiliation: US Food and Drug Administration, Silver Spring, Maryland, USA. justina.molzon@fda.hhs.gov
authors.forename: J A
authors.initials: JA
authors.lastname: Molzon
authors.forename: A
authors.initials: A
authors.lastname: Giaquinto
authors.forename: L
authors.initials: L
authors.lastname: Lindstrom
authors.forename: T
authors.initials: T
authors.lastname: Tominaga
authors.forename: M
authors.initials: M
authors.lastname: Ward
authors.forename: P
authors.initials: P
authors.lastname: Doerr
authors.forename: L
authors.initials: L
authors.lastname: Hunt
authors.forename: L
authors.initials: L
authors.lastname: Rago
mesh_terms: D003226:Congresses as Topic; D017277:Drug Approval; D005060:Europe; D017408:Guidelines as Topic; D006801:Humans; D007391:International Cooperation; D007564:Japan; D007880:Legislation, Drug; D014481:United States