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:
- This is a draft for consultation and there may therefore be changes in the final guidance document that is published towards the end of the year. Therefore, if there are areas of concerns etc in the content, these may change.
- The draft provides some very helpful additional guidance that is not present in the draft reflection paper e.g. on destruction of originals, on maintenance of multiple electronic systems.
- The draft also includes some areas that need to be challenged during the consultation process e.g. the obligation to maintain provenance of emails conflicts with the statement that only the final email in an email chain need be retained.
The draft guideline can be downloaded from the EMA website or HERE.