EU regulator steps up transparency on COVID-19 therapies

Article written by Gary Finnegan

The European Medicines Agency (EMA) has implemented extra transparency measures for COVID-19 treatments and vaccines.

The EU regulator published clinical data in support of remdesivir and new information on treatments and vaccines that have received scientific advice or guidance from the Agency’s pandemic Task Force.

The moves are the latest in ongoing efforts to build public trust in new medicines and vaccines, and to help external experts understand the science behind EMA decisions. The publication of clinical data for remdesivir is in line with regulator’s policy to proactively publish clinical data supporting applications for marketing approval.

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 challenges linked to the COVID-19 pandemic and human resource constraints.

However, the EMA has decided to exceptionally publish clinical data for COVID-19 medicines given the unprecedented public interest in this information.

The data package, consisting of 64 documents, is available on EMA’s clinical data website and includes the clinical overview and summaries, as well as the final reports from pharmacokinetic and phase I clinical studies. Interim study reports from phase III clinical studies and clinical data from the compassionate use programme are also available.

In addition, the data anonymisation report has been published. This explains the methods used to protect personal data, in line with a common approach agreed between Health Canada and the marketing authorisation holder for remdesivir.

The EMA has provided free guidance on more than 60 products. This process helps medicine developers by advising on 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.