Clinical Trials to Be Published Under European Law
Pharmaceutical companies will be made to publish all European clinical trials in a public database under a draft law passed by the European Parliament yesterday.
Marken Global Life Science Supply Chain Solutions recently reported that Members of the European Parliament amended a law that will require all clinical trials to have detailed-summaries published and available to the public. Full reports are required to be made available once a drug reaches its marketing authorization stage.
According to the publication:
…the new legislation means sponsors will submit their applications for trial approval just once via an online unified EU portal. Member states will make have to make a joint assessment and one decision at national level, within a fixed deadline.