January 20, 2022

"European Medicines Agency Launches Database Of Clinical Studies in Children Completed Before 2007"

From the European Medicines Agency:

The European Medicines Agency has published a new database containing information on studies of medicines authorised in the European Union that were carried out in children and completed before the Paediatric Regulation came into force in 2007.

The Article 45 paediatric studies database allows users to search for information on the studies’ names and aims, the medicines studied and the ages of patients included. For a subset of studies, documents summarising the study’s results are also available.

The database aims to improve the availability of information on the use of medicines in children, enabling healthcare professionals and investigators to be aware of the results studies that have been conducted on children in the past. It will also help them to avoid the unnecessary duplication of trials in children.

The Agency owns and manages the database, which has been published as part of its drive towards greater levels of transparency.

The information in the database was provided by marketing-authorisation holders. Users should direct any questions on the studies listed to the marketing-authorisation holder.

Direct to New Database

About Gary Price

Gary Price (gprice@mediasourceinc.com) is a librarian, writer, consultant, and frequent conference speaker based in the Washington D.C. metro area. Before launching INFOdocket, Price and Shirl Kennedy were the founders and senior editors at ResourceShelf and DocuTicker for 10 years. From 2006-2009 he was Director of Online Information Services at Ask.com, and is currently a contributing editor at Search Engine Land.