17 September 2013

The brochure provides a comprehensive introduction to ICH’s medical dictionary for regulatory activities and covers general aspects such as MedDRA’s features, benefits and uses, as well as more in-depth topics such as how MedDRA is structured, maintained and supported.

Through a carefully designed structure, the brochure aims to distinguish between general aspects and in-depth topics in distinct sections. This is with the intention of making the brochure valuable for a range of audience including non-technical managers/policy makers in drug regulatory authorities, public health institutes, pharmaceutical companies and academia, as well as the technical experts who work in these organisations.

The brochure was produced under the direction of the ICH MedDRA Management Board, which worked with MedDRA expert Dr. Charles Thayer to develop the document with input from communication experts and designers.

Understanding MedDRA brochure