TMG has completed updates to their Biomedical Research Site SOPs, reflecting changes described in the Integrated Addendum to ICH GCP E6(R2), that was released in November 2016. These updates have been communicated to all TMG investigative sites.
In December 2016, the regulatory authority for the European Community, the EMA, announced that they have adopted the Addendum. No other regulatory authorities have made a similar announcement.