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Elektronische Zulassung von Arzneimitteln aus Sicht des Bundesinstituts für Arzneimittel und Medizinprodukte

Dr. Uta Krischker, Dr. Jörg Lekschas und Dr. Klaus Menges

Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Bonn

Electronic Marketing Authorisation Process for Drugs from the Point of View of the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte)

Divergent previous experience in the handling of electronic submissions of marketing authorisation applications paved the way to achieving a successful, target-driven implementation for the submission ordinance within a very short time. Based on this and considering the international/European developments for implementation of the Common Technical Document (CTD) in its electronic version (eCTD), the Federal Institute for Drugs and Medical Devices (BfArM) intends to specify the rules for electronic submission so that - regardless of the type of procedure - incoming data can be sent by the pharmaceutical company in a database-conform format providing safety and considerable handling convenience.

Key words Einreichungsverordnung · Elektronische Einreichung · Elektronische Signatur · Formular-Server