China ICH Study Group Workshop on ICH M Guidelines, 25-26 October in Beijing, China

In June 2012, the ICH Global Cooperation Group endorsed a request from the Chinese State Food & Drug Administration (SFDA) for a China ICH Study Group Workshop on ICH Multidisciplinary (M) Guidelines.

The workshop took place in Beijing, China on October 25-26, 2012 and focused on electronic submission, including the use in this regard of MedDRA and ICH Guidelines M8 eCTD, E2B(R3) ICSR and M5 IDMP. Presentations were provided by experts from the Chinese SFDA, US FDA, MedDRA MSSO and industry.

Workshop attendees included participants from the Chinese SFDA (and relevant affiliates), Chinese Provincial FDAs, academia, and industry.

At a Glance...

25-26 October 2012 Beijing, China