Blog Post | Focus on Regulation | 8 June 2017

EMA publishes a Draft Guideline on Trial Master Files to facilitate the conduct and management of clinical trials

In April 2017, the European Medicines Agency (EMA) issued a draft guideline (“Draft Guideline“) concerning the Trial Master Files (“TMF”) for public consultation. The Draft Guideline updates the previous guideline on TMF that was issued in 2013 in the form of a reflection paper. The Draft Guideline incorporates further guidance concerning international guideline for good clinical practice (“ICH-GCP”) E6. Its purpose is to assist sponsors and investigators in their compliance with the requirements concerning the TMF as specified in Regulation (EU) 536/2014 on clinical trials on medicinal products (“Regulation”).

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