Today the European Medicines Agency (EMA) has implemented two further extra transparency measures for COVID-19 medicines, by publishing both the clinical data in support of the authorisation of Veklury (remdesivir) and information on the COVID-19 treatments and vaccines that have received scientific advice or informal guidance from EMA’s pandemic Task Force (COVID-ETF).
These are the latest measures in EMA’s drive to maximise the transparency of its regulatory activities on treatments and vaccines for COVID-19.
The publication of clinical data for Veklury is in line with EMA’s landmark policy to proactively publish clinical data supporting marketing authorisation applications. The Agency had to suspend the publication of clinical data at the end of 2018 as a result of its move from London to Amsterdam. It currently remains suspended due to ongoing business continuity linked to the COVID-19 pandemic and human resource constraints. EMA has decided to exceptionally publish clinical data for COVID-19 medicines given the unprecedented public interest for this information in the context of the ongoing pandemic.
The data package, consisting of 64 documents, is available on EMA’s clinical data website and includes the clinical overview and summaries and the final reports from pharmacokinetic and phase I clinical studies, as well as interim study reports from phase III clinical studies and clinical data from the compassionate use programme.
The data anonymisation report is also available. This explains the methods used to protect personal data, in line with a common approach agreed with Health Canada and the marketing authorisation holder for Veklury. Health Canada is also publishing the same data today.
The list of medicines that have received scientific advice or guidance shows the stage of development when EMA gave its guidance. This guidance, which EMA provides at no cost, helps medicine developers prepare for an eventual marketing authorisation application, and can cover the best methods and study designs for generating robust data on a medicine’s safety and effectiveness. It can also focus on quality aspects, such as manufacturing and testing, or on laboratory studies.
The outcome of any consultation or advice from EMA is not binding on developers.
EMA will update this list on a monthly basis.