Masterstudiengang "Drug Regulatory Affairs"


Elektronische Einreichung von Zulassungsunterlagen - Stand und Möglichkeiten für die Zukunft

Uta Müller (Abschlußjahr: 2002)

Industry and authorieties exchanging data electronically will become a major topic in future. Actually it is possible on a voluntary basis submitting electronic files using a special format. For example for submission to the BfArM it is possible to submit data on optical storage media using DAMOS to reduce the number of paper copies that should be submitted normally. Electronic submissions to the FDA is also possible using PDF-format. If requirements for electronic signature are fullfilled no papercopies (except covering letter and application form) are necessary.

In Germany electronic submission of labels, patient information leaflet, SPC and expert reports became mandatory since 1st January 2001. The files have to be provided via e-mail.

Based on CTD structure that has been issued by the ICH to have one single dossier structure within the ICH regions the eCTD is developing. ICH has already agreed on the eCTD specifications. ICH step 3 was finalized end July 2002, reaching ICH step 4 is expected for the next ICH conference in October 2002.

Actually another initiative in order to reach a global exchange between industry and authorities concerning pharmacovigilance data is ongoing. January 2003 industry and authorities should be prepared exchanging case reports and periodic safety update reports via internet using MedDRA terminology.

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