International – FDA, EU authorities update guidance on clinical trials during COVID-19

The European Commission and European Medicines Agency (EMA) on Tuesday updated their guidance on managing clinical trials during the coronavirus disease (COVID-19) pandemic, adding advice on distribution, data verification and communicating with authorities.

The updated guidance follows a recent similar update from the US Food and Drug Administration (FDA), which added seven new questions and answers to its document.

European Commission guidance

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, noting that the guidance will be revoked once the crisis in Europe has passed.

The updated guidance explains that sponsors may consider changes in how IMPs are distributed to avoid treatment interruptions…