Registries supporting new drug applications.

ABSTRACT:

Purpose

Knowledge of the benefits and risks of new drugs is incomplete at the time of marketing approval. Registries offer the possibility for additional, post-approval, data collection. For all new drugs, which were approved in the European Union between 2007 and 2010, we reviewed the frequency, the type, and the reason for requiring a registry.

Methods

The European Public Assessment Reports, published on the website of the European Medicine Agency, were reviewed for drugs approved by the Committee for Medicinal Products for Human Use. We searched for key characteristics of these drugs, including therapeutic area (ATC1 level), level of innovation (the score is an algorithm based on availability of treatment and therapeutic effect), and procedural characteristics. In additio

SUBMITTER: Jonker CJ 

PROVIDER: S-EPMC5725674 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature