EMA To Focus On Filings For Novel Drugs Under Restart Of Trial Transparency Policy
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.
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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.
The European Medicines Agency says the unprecedented public interest in treatments and vaccines being developed for COVID-19 has highlighted the need to provide access to more information than usual.
The European Medicines Agency has delivered on its promise to grant public access to clinical reports that form the basis of its recommendations to the European Commission on whether or not a medicine should be authorized for use in the EU.