eSubmission Management im regulatorischen Umfeld von ArzneimittelzulassungenUnterschiede und Gemeinsamkeiten in Europa und in den USA Dr. Andreas Franken Bundesverband der Arzneimittel-Hersteller e.V. (BAH), Bonn eSubmission Management in the Field of Regulations Concerning the Marketing Authorisation Process / Differences and similarities in Europe and the USA Quite a number of projects world-wide aims at reaching a partly or completely electronic data exchange between pharmaceutical industry and the authorities involved. One particular item in this context is the processing of marketing authorisations, comprising the first e-mail contact between the pharmaceutical company and the competent authority, the electronic submission of the complete marketing authorisation dossier, and the subsequent maintenance of the marketing authorisation through electronically submitted notifications of amendments, prolongation and „line extensions“. A vision in the context of these projects is to do without any paper document within these proceedings. The American regulatory authority „Food and Drug Administration“ (FDA) has been dealing with the subject of electronic submission for almost 20 years together with American industry, and the European Agency for the Evaluation of Medici-nal Products (EMEA) has been working on different projects related to this subject for about 15 years together with European industry. Due to the significant differences made by these two regulatory authorities in the review processes for examining the submitted applications, the respective projects have been focussing on different areas. While FDA has been concentrating on the submission of raw data, the European projects have been focussing on an easier handling of the summarising texts and on logical links to the results from the raw data.
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pharmind 2003, Nr. 05a, Seite 463
