EMA Guideline on TMF - open for comment

The European Medicines Agency (EMA) have issued a guideline on GCP compliance in relation to the trial master file (TMF), and invites comments from stakeholders. The guideline was compiled by the Good Clinical Practice Inspectors Working Group and the deadline for comments is 11 July 2017.

Read the guideline here: EMA Guideline

Download the template for comments here: Template

(Email completed comments form to gcp@ema.europa.eu)