WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems

This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation. This should ensure its routine use in pharmacovigilance establishments. The current manual is published as version 1 (v1.0), to underscore its evolving nature: feedback from user groups is welcomed and will be used in developing the subsequent versions.