Rammell Consulting Limited

EMA Cancels Revision of Reflection Paper on Trial Master Files


On 1st February 2013 the European Medicines Agency (EMA) released for public consultation a draft reflection paper on GCP compliance, including management of trial master files. After a three month consultation period which ended on 30th April 2013, industry has been waiting for finalisation of the reflection paper.

This week – on 15th June 2015 – EMA announced the following:

“It has been decided that the revised version of the TMF document, based on the comments collected during the public consultation, will be incorporated into a guidance on TMF as part of the work related to the implementation of the new Clinical Trial Regulation (EU) 536/2014. A public consultation on the new guidance will follow in due course.”

So, having waited for over 2 years since closure of the initial consultation period, industry has to wait a further period until this important piece of guidance is finalised. In particular, we are keen to see if EMA has responded favourably to the following criticisms of its first draft:

We await with interest publication of the next draft guidance document!