Implementation of the European QRD Template in Package Leaflets of Centralized Approved Medicines

Conclusions:
Limitation to mandatory contents through stricter use of the QRD template’s bracketing convention, which would reduce package leaflets’ text without loss of essential information, is suggested. In addition, making the current QRD template more concise is strongly recommended.

Source: Therapeutic Innovation and Regulatory Science - December 30, 2015 Category: Drugs & Pharmacology Authors: Wolf, A., Fuchs, J., Schweim, H. G. Tags: Global Perspectives Source Type: research