30 June 2011

Chinese Translation of the Value and Benefits of ICH to Drug Regulatory Authorities - Advancing Harmonization for Better Health

The ICH Study Group in China was founded in July 2009, led by the Drug Registration Department of the State Food and Drug Administration (SFDA), involving regulators and representatives from industry and academia. The objectives of the group are to study and disseminate ICH Guidelines, strengthen cooperation and exchange with ICH, and promote harmonisation of China drug registration standard with global standard. Translating and publishing ICH Guidelines and related documents are part of the important tasks.

In 2010 ICH celebrated its 20th anniversary. “The Value and Benefits of ICH to Drug Regulatory Authorities – Advancing Harmonization for Better Health” was published on the ICH website to salute two decades of the ICH’s groundbreaking work. These articles are helpful to better understand how ICH Guidelines have been implemented to benefit drug regulatory authorities to promote public health. Under such occasion, the ICH Study Group in China translated the booklet, published it into a bilingual booklet, and widely distributed it to all members and other interesting stakeholders including regulators from SFDA and its affiliates, representatives from industry and academia.

Adaptation, dissemination and utilisation of ICH Guidelines are part of a long-term and dynamic program of the group. The ICH Study Group in China will continue to engage in these activities and closely interact with ICH.

ICH 20st Anniversary Publication - Chinese Version