The Value and Benefits of the International Conference on Harmonisation (ICH) to Drug Regulatory Authorities: Advancing Harmonization for Better Public Health

Abstract

Globalization of the pharmaceutical industry has created the need to harmonize the regulatory requirements for the development of new pharmaceuticals. Experts from the pharmaceutical industry and regulators joined together to establish the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) resulting in over 60 harmonized guidelines. After agreement had been reached on these guidelines, the next logical step was to arrange the information in a common format for submission. To this end, ICH has established the Common Technical Document (CTD) and the electronic Common Technical Document (eCTD). The practical issues of implementing ICH Guidelines will be presented. Further, the value and benefit of ICH to regulators and the evolution of the CTD/eCTD as a common regulatory language will be detailed.