April 2020: EMA Updated Guidance

The European Commission and European Medicines Agency (EMA) on April 28th updated their Guidance on the Management of Clinical Trials During the COVID-19 (Coronavirus) Pandemic adding advice on distribution, data verification and communicating with authorities.  The updated EMA guidance follows an April 16th similar update from the FDA, which added seven new questions and answers to its document. The update marks the third version of the guidance from the Commission, EMA and the Heads of Medicines Agencies and provides new recommendations on the distribution of investigational medicinal products (IMPs) and data verification under social distancing measures and resource limitations.

The guidance also clarifies how clinical trial sponsors should communicate urgent issues to regulatory authorities. “The aim is to mitigate the disruption of clinical research in Europe and therefore the negative effects of the pandemic, without compromising on quality and safety,” the Commission said in April 28th press release, noting that the guidance will be revoked once the crisis in Europe has passed.

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