Rammell Consulting Limited

EMA Publishes New TMF Guideline for Consultation


The European Medicines Agency (EMA) has published (12-April-2017) a new guideline “on good clinical practice compliance in relation to trial master files” (TMF). This guideline includes and updates the guidance issued previously in the EMA draft reflection paper on trial master files, includes additional guidance from the ICH E6 revision, and provides additional guidance from the EMA based on issues experienced by industry.

I will provide a detailed assessment of the guidance over the next few days but just a few immediate thoughts based on my first read:

The draft guideline can be downloaded from the EMA website or HERE.