Clinical Trials: Letter from the SME office of the EMA

The Small and Medium-sized Enterprises (SME) office of the European Medicines Agency (EMA) has written to stakeholders on the situation regarding clinical trials during the coronavirus pandemic.

The letter states:

Dear SMEs and Stakeholders,

We would like to inform you that the European Medicines Agency (EMA) has published a draft guidance with regards to the points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials (https://www.ema.europa.eu/en/implications-coronavirus-disease-covid-19-methodological-aspects-ongoing-clinical-trials).

This guidance covers actions that sponsors of ongoing clinical trials impacted by the COVID-19 pandemic should take to help ensure the integrity of their studies and interpretation of the study results while safeguarding the safety of trial participants as a first priority.

EMA’s Biostatistics Working Party encourages affected clinical trial sponsors to seek scientific advice on these matters early in the process.

In line with this guidance, EMA will be flexible and pragmatic during the assessment of impacted clinical trial data submitted to the Agency as part of marketing authorisation applications.

The guidance is under a four-week public consultation until 25 April 2020.

Please note that further updates are possible and likely given the rapidly evolving nature of the pandemic.

Thank you.

Yours sincerely,

SME Office
Regulatory Science and Innovation Task Force

Read more on the EMA response to COVID-19 here.

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Published 27. March 2020 in News, News EU