Privatsphäre-Einstellungen

Einführung und Nutzung von elektronischen Verfahren bei der Arzneimittelzulassung

Dargestellt am Beispiel von Registrierungsaktivitäten in den Ländern Mittel- und Osteuropas

Lothar Höniger

Berlin-Chemie AG (Menarini Group), Berlin

Introduction and Use of Electronic Procedures in the Marketing Authorisation Process / Exemplified by registration activities in countries of central and eastern Europe

In the face of radical changes to regulatory processes aimed at achieving uniform global norms for the compilation of product licensing documentation, the issue of electronic registration must be addressed once more. The preliminary work by pharmaceutical companies, by European regulatory authorities and the software industry in the nineties has made it possible for the pharmaceutical companies to apply these modern technologies for registration procedures within the EU, as well as in the EU candidate countries. The expenditure and workload necessary for a small-to-medium-sized pharmaceutical company to adapt to the new registration procedures has been justified by the time gained during individual regulatory processes. Given that new innovative products are associated with documentation comprising more than 100,000 sheets of paper, there is actually no alternative to this modern electronic registration procedure. The regulatory authorities in central and eastern Europe are generally well prepared for this task and support or allow electronic submission procedures.

Key words DAMOS · eDMS eCTD · Elektronisches DokumentenManagement-System · Elektronische Zulassung eSubmission