EMA To Focus On Filings For Novel Drugs Under Restart Of Trial Transparency Policy
Executive Summary
The European Medicines Agency is working on restarting its landmark policy on publishing clinical trial data, with the first phase expected to start this year.
You may also be interested in...
EMA To Restart Landmark Clinical Trial Transparency Policy In September
The European Medicines Agency is preparing to resume proactively publishing clinical trial data submitted by companies to support their marketing authorization applications for non-COVID-19 products.
Removing Confidential Data In Clinical Trial Reports Is ‘Like Stepping On Lego’
An expert in transparency explained what drug sponsors can do to support their compliance staff in identifying commercially confidential information in accordance with the clinical trial transparency initiatives of Health Canada and the European Medicines Agency.
US ‘Lags Behind’ EU & Canada On Clinical Data Transparency
The US Food and Drug Administration has proactively released data for just one drug, compared with data released for over 100 drugs by the European Medicines Agency and just over 70 drugs by Health Canada, according to a study that compared the accessibility and comprehensiveness of the data that the three regulators proactively or reactively disclose.