10 Things You Should Know About The New TMF Regulatory Guidance

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)” – took effect on June 6, 2019. This major guidance will have a significant and far-reaching impact on your organization’s TMF processes, technology, and best practices – as well as related departments and systems.

The good news is that the new EMA guidance forms the most detailed guide to TMF best practices yet published by a regulatory agency, and in fact is becoming a de facto industry standard. Based on Phlexglobal’s extensive experience helping organizations successfully pass hundreds of regulatory inspections, following are 10 key developments that you should be aware of.