EMA's Trial Master File Guidance Is In Effect. Does Your TMF Measure Up?

By Eldin Rammell

The new European Medicines Agency (EMA) guidance on Trial Master Files – “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)” –was published on 6 December 2018.  With the guidance in effect as of June 6, 2019, there is much you should know about its impact on TMF processes, technology, and best practices.

I’ve gone through the guidance carefully, and based on my years of experience with regulatory inspections I’ve pulled out the items that will likely require changes to how you are managing Trial Master Files today.

The good news is that the new EMA guidance forms probably the most detailed guide to TMF best practices out there, and in fact is becoming a de facto industry standard. We obviously have other great regulatory frameworks for clinical trial conduct, from International Council for Harmonisation Good Clinical Practice (ICH GCP) to the Medicines and Healthcare products Regulatory Agency (MHRA) guides. The EMA guidance, however, presents practical guidance specifically for the Trial Master File.