MedDRA, the importance of harmonisation
In a world that is more and more globalised, managing international issues was made easier by legal and procedural harmonisation in every field. Tools such technical harmonisation and mutual recognition agreements were actually very important to streamline and speed up the approval of medicines, manufacturing processes, reference standards. At global level, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) represents a precious tool: in fact, the ICH gathers the regulatory authorities and pharmaceutical industries of several countries and organisations to discuss and harmonise technical and scientific aspects regarding human medicines, generating harmonised guidelines to be used as a reference point in all adhering countries. Established by the European Commission, the US FDA and the...