Privatsphäre-Einstellungen

Zukunft des regulatorischen e-Managements bei der Arzneimittelzulassung

Dr. Andreas Franken

Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn

The Future of Regulatory Affairs e-Management in the Marketing Authorisation Process

All persons involved in a marketing authorisation process aim at testing and establishing such procedures which guarantee an exclusively electronic processing of all necessary documents and data in the areas of registration of medicinal products and lifecycle-management. These procedures are intended to be internationally applicable in order to enable a global communication in this sector. This does not only involve the interests of global companies which aim at identical requirements to their activities in all regions concerned, but also authorities wanting to be able to exchange the necessary information quickly and effectively by means of identical structures and comparable formats. In this context, the persons involved do not concentrate on isolated national or European solutions but on the development of internationally harmonised specifications. The International Conference on Harmonisation (ICH) represents such a project which brings together the competent authorities and industry from the three most important trade regions in order to prepare identical guidelines to be recognised on an international level. One of ICH’s tasks is the development of general technical conditions for the electronic submission of marketing authorisation applications. By means of the so-called electronic Common Technical Document (eCTD), specifications have been developed which guarantee the technical validity of an electronic dossier simultaneously in Europe, the USA, Japan, Canada, Switzerland and several other countries associated with the ICH project.

Key words Daten-Management eCTD · EMEA · eSubmission · FDA · ICH · Regulatory affairs