, , ,

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. https://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

Name and Organisational Changes at ICH

For 25 years we’ve known ICH to be the International Conference on Harmonisation. That, however, is no longer the case! Since October 2015, ICH is officially called the International Council for Harmonisation. A strategic name change that does not change the abbreviation, however does mark the organisational changes1 that have happened within the organisation.

ICH has, in it’s 25 year existence, developed over 60 Guidelines on Quality, Safety, Efficacy and Multidisciplinary topics, in addition to products including Electronic Standards for the Transfer of Regulatory Information (ESTRI), the Common Technical Document (CTD & eCTD), and the Medical Dictionary for Regulatory Activities (MedDRA).

Read more