The Medicinal Product Registration Format

Rubrik: Fachthemen

(Treffer aus pharmind, Nr. 07, Seite 1026 (2014))

Neurauter G | Schoepke O

The Medicinal Product Registration Format / From Paper via NeeS and eCTD to Regulated Product Submission (RPS) · Neurauter G, Schoepke O · ¹EXTEDO GmbH, Ottobrunn, Germany und ²Samarind Ltd., Deeside, Flintshire, UK
The regulatory submission process went through tremendous changes over the last few years, moving away from pure paper submissions into the information technology world. Applicants as well as agencies are able to benefit from electronic documents and meta data, streamlining the submission process. Following several national initiatives in the late 90's, the ICH (International Conference on Harmonisation) established a submission format – well known as eCTD (electronic Common Technical Document) – covering the ICH regions of Europe, US and Japan. The same standard now builds the foundation of electronic submissions in a number of countries outside the ICH region, with ...