- About MedDRA
In developing and continuously maintaining MedDRA, ICH endeavours to provide a single standardised international medical terminology which can be used for regulatory communication and evaluation of data pertaining to medicinal products for human use. As a result, MedDRA is designed for use in the registration, documentation and safety monitoring of medicinal products through all phases of the development cycle (i.e., from clinical trials to post-marketing surveillance). Furthermore, MedDRA supports ICH electronic communication within the ICH’s Electronic Common Technical Document (eCTD) and the E2B Individual Case Safety Report.
The adoption of a dedicated single standardised terminology offers a number of clear advantages for regulators, industry and other stakeholders including healthcare professionals, patients and research organisations:
- Removal of the need to convert data from one terminology to another preventing the loss and/or distortion of data and allowing savings in resources;
- Improvements in the ease, quality and timeliness of data available for effective analysis, exchange and decision making;
- Consistency of the terminology throughout the different stages of the development of a medicinal product allowing effective cross-references and analysis of data;
- Facilitation of the electronic exchange of data relating to medicinal products.
In the light of these advantages, ICH is continuously pursuing the development and maintenance of MedDRA for improving the effectiveness and transparency of medical product regulation which in turn contributes to the global protection of public health.