Germany reacts to the pandemic with high attention to ongoing clinical trials. According to the government authority BfArM, protocol deviations and changes may occur with the dynamic risk situation and restrictions due to Coronavirus SARS-CoV-2.
A dedicated email, CT-COVID@bfarm.de, has been setup to respond to to inquiries on clinical trials. The subject line should state “COVID-19”. This email is not for approval requests or trial changes.
If possible, upload your question on the EUROPEAN CESP portal, a secure method of communicating with most European Regulatory Agencies via one platform.
Upcoming European Guidelines
BfArM will shortly publish European harmonized recommendations that are currently in the final coordination between the authorities.
BfArM has published information on the authorisation and conduct of clinical trials of medicinal products during the COVID-19 pandemic (Version 2.3).
For more details visit BfArM website.
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