Tuesday, September 8, 2015

Big Changes for ICH GCP and EU Regulations

 By Laurie Meehan
What GCP changes are being proposed for international clinical research?
How and when will they affect you?

What’s Changing?

Two things.

(1) The most substantial change to international guidelines in 20 years occurred earlier this year when the ICH* issued a draft addendum to its GCP guidelines, ICH E6(R2).

(2) At about the same time the guidelines go into effect, new Clinical Trial Regulation (CTR) 563/2014 will replace the current, decade-old EU Directive 2001/20.