EUROPE: COVID-19 – Overview of European Regulatory Authority Guidance by country

EUROPE: COVID-19 – Overview of European Regulatory Authority Guidance by country

Covid-19 pandemic is representing an unprecedented challenge for the governments and their healthcare and economical systems, who are working hardly to develop the proper legislative tools to face the emergency. This results in a heterogeneity of dispositions and regulations in the different States, although the European Medicines Agency (EMA) is periodically releasing recommendations and guideline on the emergency management. In particular, EU authorities have published the Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic. Nevertheless, each European State provided indications about this aspect. In order to have a clear overview of the inhomogeneous regulatory landscape among the different European Countries, a wide repository on the EMA and European Authorities regulations and recommendations has been published by EUCROF (European CRO Federation). This source is available at this link and provides an overview of guidance and information published by European Member State Regulatory Authorities concerning the conduct of clinical trials during this epidemic situation with COVID-19.

The list may undergo changes according to the emergency developments and based on the updating of the regulations of each Country, therefore it is recommended to always check on the websites of the national Agencies.

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2020-04-09T10:42:49+00:00 08/04/2020|Categories: News|