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The 6 most important updates to ICH-GCP

It’s official! TODAY, the International Council for Harmonisation (ICH), as is their new name as of October 20151, has published a press release2, declaring that they adopted revision 2 of their E6 guideline, Good Clinical Practice (ICH-GCP or ICH-E6(r2)).

As the official final guideline is not yet published on their website, currently we still have to go on the final draft3 for what the changes will be. The amazing thing about this second revision (the first constituted minor textual changes, no content changes) is that the outlined responsibilities in the original version have not changed! R2 only adds to the original text. It doesn’t change anything from what we already know and do. It mainly specifies some responsibilities and adds today’s world to a 20 year old guideline.

Read more

  1. http://fourplusmore.com/2016/08/16/changes-ich/
  2. http://www.ich.org/fileadmin/Public_Web_Site/News_room/B-Press_Releases/ICH_GCG_Press_Releases/Press_Release_Osaka_10Nov2016_Final.pdf
  3. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6/E6_R2__Addendum_Step2.pdf