Rammell Consulting Limited

Update: EMA Reflection Paper on Trial Master Files

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A while ago I posted information here regarding the draft reflection paper from the EMA on trial master files (TMF). At that point, the intention was to bring the contents of the reflection paper along with other related guidance into a single document supporting the new Clinical Trial Regulation 536/2014 and published by the European Commission / Parliament. This would be a Regulation.

It appears that the draft reflection paper will now stay with the EMA and will be issued as a guidance document in EudraLex Volume 10 (Clinical Trials Guidelines). I understand that following the prior consultation on the draft, a revised draft will be posted for final consultation in the next few weeks and will be finalised as an EMA guidance document early in 2017.

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