International Conference On Harmonisation Of Technical Requirements For Registration Of Pharmaceuticals For Human Use
2010; Brill; Linguagem: Inglês
10.1163/ej.9789004163300.i-1081.897
Autores Tópico(s)Biosimilars and Bioanalytical Methods
ResumoThe International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a combined industry and government organization. It is centrally involved in constructing and setting international technical standards for the testing, development, and monitoring of pharmaceuticals, especially in the fields of drug quality, safety, and efficacy. There are two types of memberships: full membership with voting rights; and membership that permits only 'observer' status without voting rights. The ICH Steering Committee (SC) was established in 1990 and determines the policies and procedures for ICH, selects the topics for harmonization and monitors the progress of harmonization initiatives. The core financial support for ICH is, and has been, provided by the international pharmaceutical industry trade associations. The official goal of the ICH is to harmonize inconsistent technical regulatory standards across different regions and countries in order to avoid costly, wasteful, and duplicative testing in pharmaceutical development. Keywords: drug regulatory authorities; ICH; ICH Steering Committee (SC); international pharmaceutical industry
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