Following DELACOUR’s newsletter of March 2016, in which EMA’s policy on publication of clinical data was the topic, the European Medicines Agency (EMA) has made its new database available to the public containing data from various clinical trials.
As of 20 October 2016, the EMA has provided public access to clinical reports for new medicinal products for human use authorized in the European Union in the context of marketing-authorization applications. The idea for this new open database is to give the public access to the data on which recommendations from the EMA are based, and the EMA aims for the benefit of academic research and the practice of medicine as a whole as clinical reports provide information on the methods used and results of clinical trials conducted in connection with medicinal products.
The publication of the clinical reports is based on the now adopted policy on the publication of clinical data for human medicines, which was prepared by the EMA in collaboration with concerned stakeholders. .
To access the new
database go to. On this website with the database, citizens, researchers, academics and other interested parties can read about the clinical data that has been submitted by pharmaceutical companies to support their marketing applications for human medicines submitted to the EMA on or after the clinical data policy’s entry into force on 1 January 2015.
Documents are published in the database once the European Commission decides weather or not to grant a marketing authorization, but will also be published when applications have been withdrawn before an EMA opinion has been given.
As soon as the database is fully up and running, the EMA’s goal is to publish the reports 60 days after the decision on a marketing application has been made, or within 150 days after the receipt of the withdrawal letter. The EMA aims to offer access to approximately 4,500 clinical reports per annum.
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