EMA to Release Previously Withheld Information on COVID-19 Trials
In a departure from its usual procedures, the European Medicines Agency (EMA) has announced it will release certain types of reports on COVID-19 trials not normally made public and will accelerate the publication timeline so that most information is available within one day of the agency’s receiving or taking action on trial submissions.
The EMA says it will publish for the first time a list of COVID-19 trial sponsors that have received scientific advice or guidance from the agency as well as announcing new COVID-related marketing authorization applications within one day of receiving them. The EMA also will publish the start date of the accelerated “rolling review” of each new application within one day of beginning the review.
Deidentified COVID-19 clinical trial data will be published on the EMA’s clinical data website as soon as marketing authorization has been awarded, the agency says. Publication of data for all types of clinical trials previously had been put on hold while the EMA moved its headquarters from London to Amsterdam.
And for the first time, trials’ full risk-management plans will be released.
The new procedures apply only to trials of COVID-19 vaccines and therapies, the EMA says, adding that it may choose to “increase transparency of other regulatory procedures” as well.
The EMA statement “Transparency: Exceptional Measures for COVID-19 Medicines” can be found at: https://bit.ly/3eeINyo.